It is a huge Warning Letter, so in quick summary:
- Did not have a food safety plan with the required elements for any of the products manufactured at the facility.
- Did not have proper controls in place for a cooked RTE product (w/pH > 4.6 and Aw close to 0.99) that could potentially support the growth of sporeforming pathogens such as B. cereus and C.botulinum. Specifically time/temperature controls.
- Did not develop and implement controls for allergens or mycotoxins.
- A huge list of GMP violations were noted.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lucky-kt-co-inc-659663-01262024
WARNING LETTER
Lucky K.T. Co., Inc.
MARCS-CMS 659663 — JANUARY 26, 2024
WARNING LETTER
Lucky K.T. Co., Inc.
MARCS-CMS 659663 — JANUARY 26, 2024
Recipient:
Mr. Huu Q. Thong
Manager
Lucky K.T. Co., Inc.
10925 Schmidt Rd
El Monte, CA 91733
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
January 26, 2024
WL 659663
Dear Mr. Thong:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 10925 Schmidt Rd, El Monte, CA 91733 on April 18, 2023, through May 11, 2023. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings and analytical results for finished product samples of Fresh Rice Noodle and Rice Stick Noodle, we have determined that the noodle products manufactured in your facility (i.e., Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle) are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your noodle products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the FDA 483 dated June 2, 2023, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR §117.126(a)(2), and your food safety plan must include the following:
The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
The written preventive controls, as required by 21 CFR § 117.135(b);
The written supply-chain program, as required by Subpart G;
The written recall plan, as required by 21 CFR § 117.139(a);
The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with the required elements for any of the products manufactured by your facility (i.e., Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle). For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
A. You did not identify and evaluate bacterial pathogen growth and/or toxin formation of pathogens, such as Bacillus cereus and/or Clostridium botulinum, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control.
i. Your facility manufactures Fresh Rice Noodle and Rice Stick Noodle products in (b)(4). Your firm indicated that you (b)(4) your Fresh Rice Noodle at (b)(4) for approximately (b)(4) and your Rice Stick Noodle at (b)(4) for (b)(4). You have not demonstrated that (b)(4) will destroy spore formers and/or toxin formers and do not monitor the (b)(4) process. The packaged food does not receive any further lethal treatment at your facility that would significantly minimize the pathogen. You do not have controls in place for bacterial growth and/or toxin formation for pathogens such as Clostridium botulinum due to lack of time/temperature control, or formulation controls as evidenced by the following:
You stated the packaged Rice Stick Noodle products are stored in the (b)(4) for about (b)(4) and distributed via company vans under (b)(4) temperatures to your customers in (b)(4), which may take anywhere from (b)(4) to (b)(4). The Fresh Rice Noodle products that are packaged (b)(4) are held at (b)(4) temperatures for up to (b)(4) before distribution via company vans, which can add up an additional (b)(4) at (b)(4) temperature.
Your firm adds (b)(4) of the finished product (b)(4), however you do not monitor the pH of your Rice Stick Noodle product. You stated you have not used the pH meter for monitoring since you first bought it. Further FDA sample analysis showed that your Fresh Rice Noodle and Rice Stick Noodle are not consistently achieving a pH and water activity that would control pathogens such as Clostridium botulinum and B. cereus spores.
o FDA sample of Fresh Rice Noodle, was analyzed and found a pH range of 6.93 - 7.52 (original analysis) and 6.35 to 7.40 (check analysis. Water activity was found to be 0.999-1.00 (original analysis) and 1.00 (check analysis).
o FDA sample of Lucky K.T. brand Rice Stick Noodle was analyzed and found a pH range of 3.37 - 5.16 (original analysis) and 3.28 to 4.91 (check analysis). Water activity was found to be 0.998-0.999 and 0.996-1.000 (check analysis).
ii. Your manufacturing process for Fresh Rice Noodle and Rice Stick Noodle includes (b)(4) rice for (b)(4) at (b)(4) temperature. Your firm indicated that you (b)(4) your Fresh Rice Noodle at (b)(4) for approximately (b)(4) and your Rice Stick Noodle at (b)(4) for (b)(4). You have not demonstrated that (b)(4) will destroy spore formers and/or toxin formers and do not monitor the (b)(4) process. The packaged food does not receive any further lethal treatment at your facility that would significantly minimize the pathogen. You do not have controls in place for bacterial growth and/or toxin formation for pathogens such as Bacillus cereus due to lack of time/temperature control, or formulation controls as evidenced by the following:
During the inspection, on the Fresh Rice Noodle line, the investigator observed (b)(4) rice sat at (b)(4) temperatures, ranging from (b)(4), for approximately (b)(4) before undergoing (b)(4).
During the inspection, on the Rice Stick Noodle line, the investigator observed (b)(4) rice sat at (b)(4) temperatures, ranging from (b)(4), for approximately (b)(4) before undergoing (b)(4).
These (b)(4) practices may contribute to potential B. cereus growth and toxin formation and as noted above, FDA samples revealed that your firm does not have formulation controls to inhibit the growth of B. cereus spores. Additionally, the noodles may be held and transported at (b)(4) temperature for (b)(4).
B. You did not identify or evaluate allergens as a known or reasonably foreseeable hazard requiring a preventive control. You manufacture various noodle products that contain allergens (such as wheat and egg). Products containing different allergen profiles are processed on shared equipment and using shared utensils on the same production day. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).
i. You do not have controls in place for the allergen cross-contact hazard as evidenced by the following:
On (b)(4), at approximately (b)(4), your firm was processing Pancit Noodles (egg-less noodles) using the same equipment used to produce Egg Noodles earlier in the day. The shared equipment, including the weighing scales and (b)(4) trays, already had white and yellow food debris buildup adhering to them, as well as an orange-brown discoloration on the scales.
ii. You do not have controls in place for undeclared allergens due to the incorrect label as evidenced by the following:
Your Egg Noodle, and Pancit Noodle products are manufactured using enriched flour, which contains wheat; however, the finished product labels for Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.) do not declare the major food allergen wheat.
C. You did not identify or evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. You manufacture Fresh Rice Noodle, Rice Stick Noodle, Pancit Noodle, and Egg Noodle products, which all contain rice and/or wheat flour as ingredients. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
Your response stated that you hired a consultant to develop food safety plans by 6/16/2023, with implementation by 7/17/2023. However, we cannot assess the adequacy of your stated corrective actions because you have not provided your food safety plan or implementation records. (b)(5).
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
1. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.10. Specifically, the following was observed:
a. On 4/20/2023, employees returned from break to the Fresh Rice Noodle cutting and packaging area without washing their hands. One employee, responsible for folding the (b)(4) Fresh Rice Noodle sheets, touched his ear and immediately handled the Fresh Rice Noodles with his bare hands. Other employees folded and carried stacks of cooked Fresh Rice Noodle sheets over their bare hands and forearms to prepare them for cutting and packaging.
b. On 4/26/2023, two employees were packaging (b)(4) Rice Stick Noodles while wearing their watches and rings. They were handling sheets of uncut and cut Rice Stick Noodles, bundling them, and grabbing them with their bare hands to place them into plastic bags. As the noodles are flexible, strands of noodles occasionally wrapped around the hands and wrists of the employees.
c. On 4/26/2023, an employee stored his cell phone on the worktable, directly adjacent to the Egg Noodles he was (b)(4). The employee’s cell phone was covered in white powder and Egg Noodle.
d. On 4/26/2023, an employee with long arm hairs was weighing and packaging (b)(4) Egg Noodles using his bare hands, and the noodles came into direct contact with his forearms.
e. On 4/18/2023, personal belongings, including a sweatshirt, two lunch bags, and a water bottle, were stored on the top surface of table where (b)(4) Rice Stick Noodles are cut and packaged.
Your response stated that you developed a written Good Manufacturing Practice program on 05/24/2023 that will include (b)(4) inspections of employee practices and training, which was targeted for completion by (b)(4). You also state that lockers will be purchased for storage of all personal items and will be installed on or before (b)(4). Further, you provided photographs of gloves, plastic arm sleeves, and plastic aprons, which you state that employees are required to wear. (b)(5).
2. Your equipment and utensils were not designed and constructed as to be adequately cleanable and were not adequately maintained to protect against allergen cross-contact and contamination, as required by 21 CFR § 117.40. Specifically, the following were observed:
a. On 4/19/2023, an employee (b)(4) Egg Noodles was placing rounds of (b)(4) Egg Noodles directly on top of cardboard boxes, which had absorbed oil over time, and turned dark as a result.
b. On 4/21/2023, employees were (b)(4) Pancit Noodles in a two-compartment sink filled with milky-colored water in order to (b)(4) before packaging. Employees then transferred the noodles to a tall, white plastic container, filled with milky-colored water, (b)(4). The plastic container contained black and brown residues and showed signs of abrasion and cracking. The (b)(4) Pancit Noodles were (b)(4).
c. On 4/26/2023, a pot, submerged in a bucket containing (b)(4) and (b)(4), was used to measure and add the mixture into Mixer Tank (b)(4) of the Rice Stick Noodle (b)(4). The handle of the pot, which appeared to be rusted, was also partially (b)(4).
d. On 5/10/2023, the interior of the wash tank in the Fresh Rice Noodle line, used for (b)(4) and (b)(4) rice in water, had a crusty build-up of white, black, and yellow residue. The buildup was most apparent on the uneven seams of the wash tank. You stated the employees had already washed this line.
Your response stated that you will train employees, ensure that they have the proper tools/equipment to handle food products correctly, and inspect and, if needed, replace all plastic containers and metal screens. Also, you indicated that you have thoroughly cleaned and inspected your wash tank, will inspect it (b)(4), and will develop proper cleaning procedures for it. We cannot assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records, cleaning procedures or sanitation monitoring records. (b)(5).
3. You did not clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.35(d). Specifically, the following were observed:
a. On 4/18/2023, there was an orange-colored residue on the surface of the water pump inside the rice (b)(4) tank of the Rice Stick Noodle line. The tank was filled with water and rice, submerging the water pump, and exposing the rice to the orange residue.
b. On 4/18/2023, there was a white-colored buildup on the pipes, electrical tubing, and water tubing in and around the wash tank and grinder of the Rice Stick Noodle line. The pipes and tubes came into direct contact with the rice and water. Additionally, water droplets from spraying water were forming and dripping from these pipes and tubes, directly above exposed (b)(4) rice and (b)(4).
c. On 4/19/2023, a dirty copper water pipe was submerged inside rice and water in the rice (b)(4) tank; a rusty release lever was located approximately 4 inches above the grinder hopper of the wash tank, over exposed rice; and the grinder hopper containing rice appeared rusted or deteriorated.
d. On 4/21/2023, a white buildup was observed on the surface of a 2-compartment sink immediately before an employee began washing and (b)(4) Pancit Noodles in the sink. Further, there was a brown residue along the wall directly connected to the sink, greenish buildup along the base of the faucet, a yellow residue on the faucet knobs, and a dirty hose submerged in one of the compartments filled with water for cleaning the noodles.
e. On 4/21/2023, two employees were weighing (b)(4) Pancit Noodles with (b)(4) tabletop scales that had pink and brown-colored residue adhering to the face of the scale dial and underneath the scale plate. The back of the scale had a white and orange buildup and rusty screws, and the scales appeared to have peeling paint, deep seams, and discolored surfaces. The piles of noodles on the table, and the noodles being weighed, all came into direct contact with the scale surfaces.
f. On 5/10/2023, an employee was rinsing Egg Noodles (b)(4) them, in a sink that had brown/black residue adhering to the edges. The noodles were placed into the sink filled with water and they came into contact with the unclean surfaces of the sink while being removed.
g. On 5/10/2023, Egg Noodles were hanging out of, and touching, the dirty exterior of the white bins they were being held in (b)(4). Additionally, the white bins were stacked on top of each other on a (b)(4) covered with yellow, white, and black build-up, and strands of Egg Noodles hanging out of the white bins came in contact with the dirty cart.
Your response stated that you have or will thoroughly clean, inspect, and as appropriate replace the referenced equipment and utensils. You also stated that you will develop proper cleaning procedures. Further, you indicated that you will inspect the equipment and utensils (b)(4) and document the inspection. You also indicated that you will inspect for condensation (b)(4) and document the inspection. You provided photographs of what appears to be clean equipment. We cannot fully assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records, cleaning procedures or other records documenting implementation. (b)(5).
4. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, the following were observed:
a. On 4/18/2023, throughout the day, at least 5 apparent birds were flying in the warehouse, rice noodle production area, and egg noodle production area.
b. On 4/18/2023, at least 10 apparent winged insects were crawling on the walls adjacent to the rice wash tank and inside the exhaust vents directly above Mixer Tanks (b)(4) and (b)(4) of the Rice Stick Noodle line.
c. On 4/19/2023, a hole in the wall, less than a foot away from the rice soak tank of the Rice Stick Noodle line, contained remnants of old rice and apparent worm-like insects.
d. On 4/19/2023, at least 3 apparent cockroach-like insects were hiding amidst the electrical wiring structure of the wash tank, located adjacent to the rice grinder and directly above the rice soak tanks. On the same day, 1 apparent cockroach-like insect was dead, on top of the rice (b)(4), directly beneath the electrical tubing.
e. On 4/19/2023, at least 4 apparent birds flew out from behind the Pancit/Egg Noodle (b)(4) equipment. The roll-up door was fully open, and the side door to the outside was slightly open, during various times throughout the day. On the night of 4/19-20/2023, the loading door was left open by employees. You closed the door when it was pointed out by our investigator, but it was later found wide open again.
f. On 4/19/2023, at least 1 apparent bird was observed walking around the noodle frying station, where both packaged and unpackaged deep-fried noodles were sitting atop cardboard boxes.
g. On 4/26/2023, 1 apparent dead mouse was observed between pallets of (b)(4) and (b)(4) in the raw material warehouse.
Your response stated that you will meet with a third-party pest control operator by 06/02/2023 to address the observations. However, you have not provided any additional corrective actions. (b)(5).
5. You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, the following were observed:
a. Walls and ceilings (area greater than (b)(4)) adjacent to and directly above the rice stick noodle soak tanks and wash tank had yellow and brown buildup adhering to them.
b. The floors throughout the facility, in walkways, and directly beneath and adjacent to processing equipment, are pitted and cracked.
c. There was a pink, yellow, and brown buildup on an area of the floor, approximately (b)(4) in size, located behind the rice grinder of the Rice Stick Noodle line.
d. The walls and floors adjacent to the 2-compartment wash sink and Fresh Rice Noodle wash tank had a brown and yellow buildup.
e. The walls and floors adjacent to the 2-compartment wash sink in the Egg Noodle room had apparent yellow and brown buildup.
Your response stated that you cleaned the walls and ceilings above the rice stick noodle soak tanks and wash tank area and that you will inspect them (b)(4) and document the inspection. Further, you provided a photograph of this area. You also indicated that you will develop proper cleaning procedures for the ceiling and walls and will obtain a quote for the floors in the production area. We cannot fully assess the adequacy of your corrective actions because you have not provided documentation such as your cleaning procedures or records, other than the photograph mentioned above, documenting implementation. (b)(5).
6. You did not properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant, as required by 21 CFR § 117.20(a)(1). Specifically, the following were observed:
a. The exterior facility walls had an over-growth of vegetation. Specifically, on the exterior wall containing the pedestrian door and loading dock door of the Egg Noodle production room, there was an overgrowth of plants above the pedestrian door, and both doors were left open during employee breaks and production breaks.
b. The uncovered trash bins outside of the facility in the front parking lot contained food waste, and on 5/10/2023, at least 7 birds were eating from scraps around the trash bins.
Your response stated that you removed vegetation and will remove it on (b)(4) basis going forward. You also indicated that you trained employees regarding open doors and proper trash storage and will inspect the trash area (b)(4). Further, you will remove the vegetation and clean the trash storage area as part of your Master Sanitation Schedule. We cannot fully assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records or your Master Sanitation Schedule. (b)(5).
Misbranding Violations
1. Your Egg Noodle (5 lb.) and Pancit Noodle (16 oz./1 lb.) products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the finished product labels fail to declare the major food allergen “wheat” as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, your Egg Noodle (5 lb.) and Pancit Noodle (16 oz./1 lb.) products are manufactured using enriched flour, which contains “wheat.”
2. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.), Steamed Chow Mein (14 oz.), and Rice Noodle (16 oz./1 lb., 2 lb., 5 lb.) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label by its common or usual name, as required by 21 CFR 101.4. For example:
a. Egg Noodle (5 lb.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
iii. The product label declares “fresh eggs” while your product formulation indicates the product is manufactured using (b)(4).
iv. The product formulation lists both (b)(4) flour and (b)(4) wheat, neither of which are declared in the ingredient statement.
v. The percent declaration for “potassium carbonate” in the ingredient list is not declared in accordance with 21 CFR 101.4(e).
b. Pancit Noodle (16 oz./1 lb.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
iii. The product formulation indicates the Pancit Noodle product is manufactured using (b)(4), which is not declared on the product label.
iv. The percent declaration for “potassium carbonate” in the ingredient list is not declared in accordance with 21 CFR 101.4(e).
v. The ingredient “(b)(4)” is not declared in accordance with 21 CFR 101.4(b)(14).
c. Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.)
i. The product label declares “Enriched Rice,” which is a standardized food under 21 CFR 137.350. However, the product label fails to include the required sub-ingredients for “enriched rice.”
ii. The product formulation indicates the Rice Stick Noodle product is manufactured using (b)(4) and (b)(4) none of which are declared on the product labels.
iii. The ingredient “(b)(4)” is not declared in accordance with 21 CFR 101.4(b)(14).
iv. The label for the 16oz/1 lb. Rice Stick Noodle lists “contains (b)(4) products,” which is also not a common or usual name of an ingredient.
d. Rice Noodle (16 oz./1 lb. and 5 lb.)
i. The product label declares “Enriched Rice,” which is a standardized food under 21 CFR 137.350. However, the product label fails to include the required sub-ingredients for “enriched rice.”
ii. The product formulation indicates the Rice Noodle products are manufactured using (b)(4) and (b)(4), which are not declared on the Rice Noodle (16 oz./1 lb., 2 lb., 5 lb.) product labels.
iii. The product labels declare “potato starch” which is not listed as an ingredient on the product formulation.
e. Steamed Chow Mein (14 oz.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product formulation indicates the Steamed Chow Mein product is manufactured using (b)(4), which is not declared on the product label.
iii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
3. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), Rice Noodle (5 lb.), and Rice Stick Noodle (16 oz/1 lb.) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in accordance with the requirements in 21 CFR 101.9. For example:
a. Your Egg Noodle (5 lb.) and Rice Stick Noodle (16 oz./1 lb.) product labels do not include the following required information: Total Sugars, Added Sugars, Potassium, and Vitamin D, in accordance with 21 CFR 101.9(c). The labels also include a declaration of “Calories from Fat” which is no longer permitted in the updated nutrition facts label (NFL), and the footnote is not in accordance with 21 CFR 101.9(d)(9).
b. Your Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), and Rice Noodle (5 lb.) product labels fail to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b)]. The Pancit and Steamed Chow Mein product labels declare serving sizes of 1 oz. (28g), and the Rice Noodle (5 lb.) label declares 10 oz.; however, the appropriate RACC for noodles is (b)(4), and (b)(4), with a label statement of 2 oz. (56g/visual unit of measure). Therefore, all nutrient amounts are incorrectly declared.
4. Your Egg Noodle (5 lb.) product is misbranded within the meaning of 403(g) of the Act [21 U.S.C. 343(g)]. The product is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the Act and the food does not appear to conform to such definition and standard, in accordance with 21 CFR 139.150. Specifically, your Egg Noodle product contains ingredients, such as FD&C Yellow #5, that are not optional ingredients for this food. See comments below for additional information.
5. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.), and Rice Noodle (5 lb.) products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)]. If a label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear in the foreign language, as required by 21 CFR 101.15(c)(2). For example, the Nutrition Facts labels must be declared in all languages.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Additional Comments
You did not identify and evaluate the hazard of contamination with environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture RTE noodles such as Fresh Rice Noodle and Rice Stick Noodle which are exposed to the environment while they are (b)(4) sliced, packaged, and (b)(4) step. If you identify environmental pathogens as a hazard requiring a preventive control, you are required to implement preventive controls, such as sanitation controls, to provide assurances that this hazard will be significantly minimized or prevented (see 21 CFR 117.135(c)(3)). Further, if contamination with an environmental pathogen is a hazard requiring a preventive control, you must conduct environmental monitoring to verify that your controls are effective (see 21 CFR 117.165(a)(3)).
You did not identify and evaluate the hazard of vegetative pathogens associated with your ingredients and survival of your (b)(4) process as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture RTE noodles such as Fresh Rice Noodle and Rice Stick Noodle products.
Please refer to “CPG Section 505.400 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles (Labeling)” regarding FDA’s policy regarding naming this product. Under this CPG, we do not object to “Oriental-style noodles” being labeled as “noodles,” when a descriptor or qualifying term precedes the term “noodle.”
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent electronically to: orahafwest5firmresponses@fda.hhs.gov.
Otherwise, a hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations West - Division 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number, CMS 659663, when replying. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at clarice.ahn@fda.hhs.gov, or 510-337-6854.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations - West Division 5
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 10925 Schmidt Rd, El Monte, CA 91733 on April 18, 2023, through May 11, 2023. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings and analytical results for finished product samples of Fresh Rice Noodle and Rice Stick Noodle, we have determined that the noodle products manufactured in your facility (i.e., Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle) are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your noodle products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the FDA 483 dated June 2, 2023, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR §117.126(a)(2), and your food safety plan must include the following:
The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
The written preventive controls, as required by 21 CFR § 117.135(b);
The written supply-chain program, as required by Subpart G;
The written recall plan, as required by 21 CFR § 117.139(a);
The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with the required elements for any of the products manufactured by your facility (i.e., Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle). For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
A. You did not identify and evaluate bacterial pathogen growth and/or toxin formation of pathogens, such as Bacillus cereus and/or Clostridium botulinum, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control.
i. Your facility manufactures Fresh Rice Noodle and Rice Stick Noodle products in (b)(4). Your firm indicated that you (b)(4) your Fresh Rice Noodle at (b)(4) for approximately (b)(4) and your Rice Stick Noodle at (b)(4) for (b)(4). You have not demonstrated that (b)(4) will destroy spore formers and/or toxin formers and do not monitor the (b)(4) process. The packaged food does not receive any further lethal treatment at your facility that would significantly minimize the pathogen. You do not have controls in place for bacterial growth and/or toxin formation for pathogens such as Clostridium botulinum due to lack of time/temperature control, or formulation controls as evidenced by the following:
You stated the packaged Rice Stick Noodle products are stored in the (b)(4) for about (b)(4) and distributed via company vans under (b)(4) temperatures to your customers in (b)(4), which may take anywhere from (b)(4) to (b)(4). The Fresh Rice Noodle products that are packaged (b)(4) are held at (b)(4) temperatures for up to (b)(4) before distribution via company vans, which can add up an additional (b)(4) at (b)(4) temperature.
Your firm adds (b)(4) of the finished product (b)(4), however you do not monitor the pH of your Rice Stick Noodle product. You stated you have not used the pH meter for monitoring since you first bought it. Further FDA sample analysis showed that your Fresh Rice Noodle and Rice Stick Noodle are not consistently achieving a pH and water activity that would control pathogens such as Clostridium botulinum and B. cereus spores.
o FDA sample of Fresh Rice Noodle, was analyzed and found a pH range of 6.93 - 7.52 (original analysis) and 6.35 to 7.40 (check analysis. Water activity was found to be 0.999-1.00 (original analysis) and 1.00 (check analysis).
o FDA sample of Lucky K.T. brand Rice Stick Noodle was analyzed and found a pH range of 3.37 - 5.16 (original analysis) and 3.28 to 4.91 (check analysis). Water activity was found to be 0.998-0.999 and 0.996-1.000 (check analysis).
ii. Your manufacturing process for Fresh Rice Noodle and Rice Stick Noodle includes (b)(4) rice for (b)(4) at (b)(4) temperature. Your firm indicated that you (b)(4) your Fresh Rice Noodle at (b)(4) for approximately (b)(4) and your Rice Stick Noodle at (b)(4) for (b)(4). You have not demonstrated that (b)(4) will destroy spore formers and/or toxin formers and do not monitor the (b)(4) process. The packaged food does not receive any further lethal treatment at your facility that would significantly minimize the pathogen. You do not have controls in place for bacterial growth and/or toxin formation for pathogens such as Bacillus cereus due to lack of time/temperature control, or formulation controls as evidenced by the following:
During the inspection, on the Fresh Rice Noodle line, the investigator observed (b)(4) rice sat at (b)(4) temperatures, ranging from (b)(4), for approximately (b)(4) before undergoing (b)(4).
During the inspection, on the Rice Stick Noodle line, the investigator observed (b)(4) rice sat at (b)(4) temperatures, ranging from (b)(4), for approximately (b)(4) before undergoing (b)(4).
These (b)(4) practices may contribute to potential B. cereus growth and toxin formation and as noted above, FDA samples revealed that your firm does not have formulation controls to inhibit the growth of B. cereus spores. Additionally, the noodles may be held and transported at (b)(4) temperature for (b)(4).
B. You did not identify or evaluate allergens as a known or reasonably foreseeable hazard requiring a preventive control. You manufacture various noodle products that contain allergens (such as wheat and egg). Products containing different allergen profiles are processed on shared equipment and using shared utensils on the same production day. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).
i. You do not have controls in place for the allergen cross-contact hazard as evidenced by the following:
On (b)(4), at approximately (b)(4), your firm was processing Pancit Noodles (egg-less noodles) using the same equipment used to produce Egg Noodles earlier in the day. The shared equipment, including the weighing scales and (b)(4) trays, already had white and yellow food debris buildup adhering to them, as well as an orange-brown discoloration on the scales.
ii. You do not have controls in place for undeclared allergens due to the incorrect label as evidenced by the following:
Your Egg Noodle, and Pancit Noodle products are manufactured using enriched flour, which contains wheat; however, the finished product labels for Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.) do not declare the major food allergen wheat.
C. You did not identify or evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. You manufacture Fresh Rice Noodle, Rice Stick Noodle, Pancit Noodle, and Egg Noodle products, which all contain rice and/or wheat flour as ingredients. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
Your response stated that you hired a consultant to develop food safety plans by 6/16/2023, with implementation by 7/17/2023. However, we cannot assess the adequacy of your stated corrective actions because you have not provided your food safety plan or implementation records. (b)(5).
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
1. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.10. Specifically, the following was observed:
a. On 4/20/2023, employees returned from break to the Fresh Rice Noodle cutting and packaging area without washing their hands. One employee, responsible for folding the (b)(4) Fresh Rice Noodle sheets, touched his ear and immediately handled the Fresh Rice Noodles with his bare hands. Other employees folded and carried stacks of cooked Fresh Rice Noodle sheets over their bare hands and forearms to prepare them for cutting and packaging.
b. On 4/26/2023, two employees were packaging (b)(4) Rice Stick Noodles while wearing their watches and rings. They were handling sheets of uncut and cut Rice Stick Noodles, bundling them, and grabbing them with their bare hands to place them into plastic bags. As the noodles are flexible, strands of noodles occasionally wrapped around the hands and wrists of the employees.
c. On 4/26/2023, an employee stored his cell phone on the worktable, directly adjacent to the Egg Noodles he was (b)(4). The employee’s cell phone was covered in white powder and Egg Noodle.
d. On 4/26/2023, an employee with long arm hairs was weighing and packaging (b)(4) Egg Noodles using his bare hands, and the noodles came into direct contact with his forearms.
e. On 4/18/2023, personal belongings, including a sweatshirt, two lunch bags, and a water bottle, were stored on the top surface of table where (b)(4) Rice Stick Noodles are cut and packaged.
Your response stated that you developed a written Good Manufacturing Practice program on 05/24/2023 that will include (b)(4) inspections of employee practices and training, which was targeted for completion by (b)(4). You also state that lockers will be purchased for storage of all personal items and will be installed on or before (b)(4). Further, you provided photographs of gloves, plastic arm sleeves, and plastic aprons, which you state that employees are required to wear. (b)(5).
2. Your equipment and utensils were not designed and constructed as to be adequately cleanable and were not adequately maintained to protect against allergen cross-contact and contamination, as required by 21 CFR § 117.40. Specifically, the following were observed:
a. On 4/19/2023, an employee (b)(4) Egg Noodles was placing rounds of (b)(4) Egg Noodles directly on top of cardboard boxes, which had absorbed oil over time, and turned dark as a result.
b. On 4/21/2023, employees were (b)(4) Pancit Noodles in a two-compartment sink filled with milky-colored water in order to (b)(4) before packaging. Employees then transferred the noodles to a tall, white plastic container, filled with milky-colored water, (b)(4). The plastic container contained black and brown residues and showed signs of abrasion and cracking. The (b)(4) Pancit Noodles were (b)(4).
c. On 4/26/2023, a pot, submerged in a bucket containing (b)(4) and (b)(4), was used to measure and add the mixture into Mixer Tank (b)(4) of the Rice Stick Noodle (b)(4). The handle of the pot, which appeared to be rusted, was also partially (b)(4).
d. On 5/10/2023, the interior of the wash tank in the Fresh Rice Noodle line, used for (b)(4) and (b)(4) rice in water, had a crusty build-up of white, black, and yellow residue. The buildup was most apparent on the uneven seams of the wash tank. You stated the employees had already washed this line.
Your response stated that you will train employees, ensure that they have the proper tools/equipment to handle food products correctly, and inspect and, if needed, replace all plastic containers and metal screens. Also, you indicated that you have thoroughly cleaned and inspected your wash tank, will inspect it (b)(4), and will develop proper cleaning procedures for it. We cannot assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records, cleaning procedures or sanitation monitoring records. (b)(5).
3. You did not clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.35(d). Specifically, the following were observed:
a. On 4/18/2023, there was an orange-colored residue on the surface of the water pump inside the rice (b)(4) tank of the Rice Stick Noodle line. The tank was filled with water and rice, submerging the water pump, and exposing the rice to the orange residue.
b. On 4/18/2023, there was a white-colored buildup on the pipes, electrical tubing, and water tubing in and around the wash tank and grinder of the Rice Stick Noodle line. The pipes and tubes came into direct contact with the rice and water. Additionally, water droplets from spraying water were forming and dripping from these pipes and tubes, directly above exposed (b)(4) rice and (b)(4).
c. On 4/19/2023, a dirty copper water pipe was submerged inside rice and water in the rice (b)(4) tank; a rusty release lever was located approximately 4 inches above the grinder hopper of the wash tank, over exposed rice; and the grinder hopper containing rice appeared rusted or deteriorated.
d. On 4/21/2023, a white buildup was observed on the surface of a 2-compartment sink immediately before an employee began washing and (b)(4) Pancit Noodles in the sink. Further, there was a brown residue along the wall directly connected to the sink, greenish buildup along the base of the faucet, a yellow residue on the faucet knobs, and a dirty hose submerged in one of the compartments filled with water for cleaning the noodles.
e. On 4/21/2023, two employees were weighing (b)(4) Pancit Noodles with (b)(4) tabletop scales that had pink and brown-colored residue adhering to the face of the scale dial and underneath the scale plate. The back of the scale had a white and orange buildup and rusty screws, and the scales appeared to have peeling paint, deep seams, and discolored surfaces. The piles of noodles on the table, and the noodles being weighed, all came into direct contact with the scale surfaces.
f. On 5/10/2023, an employee was rinsing Egg Noodles (b)(4) them, in a sink that had brown/black residue adhering to the edges. The noodles were placed into the sink filled with water and they came into contact with the unclean surfaces of the sink while being removed.
g. On 5/10/2023, Egg Noodles were hanging out of, and touching, the dirty exterior of the white bins they were being held in (b)(4). Additionally, the white bins were stacked on top of each other on a (b)(4) covered with yellow, white, and black build-up, and strands of Egg Noodles hanging out of the white bins came in contact with the dirty cart.
Your response stated that you have or will thoroughly clean, inspect, and as appropriate replace the referenced equipment and utensils. You also stated that you will develop proper cleaning procedures. Further, you indicated that you will inspect the equipment and utensils (b)(4) and document the inspection. You also indicated that you will inspect for condensation (b)(4) and document the inspection. You provided photographs of what appears to be clean equipment. We cannot fully assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records, cleaning procedures or other records documenting implementation. (b)(5).
4. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, the following were observed:
a. On 4/18/2023, throughout the day, at least 5 apparent birds were flying in the warehouse, rice noodle production area, and egg noodle production area.
b. On 4/18/2023, at least 10 apparent winged insects were crawling on the walls adjacent to the rice wash tank and inside the exhaust vents directly above Mixer Tanks (b)(4) and (b)(4) of the Rice Stick Noodle line.
c. On 4/19/2023, a hole in the wall, less than a foot away from the rice soak tank of the Rice Stick Noodle line, contained remnants of old rice and apparent worm-like insects.
d. On 4/19/2023, at least 3 apparent cockroach-like insects were hiding amidst the electrical wiring structure of the wash tank, located adjacent to the rice grinder and directly above the rice soak tanks. On the same day, 1 apparent cockroach-like insect was dead, on top of the rice (b)(4), directly beneath the electrical tubing.
e. On 4/19/2023, at least 4 apparent birds flew out from behind the Pancit/Egg Noodle (b)(4) equipment. The roll-up door was fully open, and the side door to the outside was slightly open, during various times throughout the day. On the night of 4/19-20/2023, the loading door was left open by employees. You closed the door when it was pointed out by our investigator, but it was later found wide open again.
f. On 4/19/2023, at least 1 apparent bird was observed walking around the noodle frying station, where both packaged and unpackaged deep-fried noodles were sitting atop cardboard boxes.
g. On 4/26/2023, 1 apparent dead mouse was observed between pallets of (b)(4) and (b)(4) in the raw material warehouse.
Your response stated that you will meet with a third-party pest control operator by 06/02/2023 to address the observations. However, you have not provided any additional corrective actions. (b)(5).
5. You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, the following were observed:
a. Walls and ceilings (area greater than (b)(4)) adjacent to and directly above the rice stick noodle soak tanks and wash tank had yellow and brown buildup adhering to them.
b. The floors throughout the facility, in walkways, and directly beneath and adjacent to processing equipment, are pitted and cracked.
c. There was a pink, yellow, and brown buildup on an area of the floor, approximately (b)(4) in size, located behind the rice grinder of the Rice Stick Noodle line.
d. The walls and floors adjacent to the 2-compartment wash sink and Fresh Rice Noodle wash tank had a brown and yellow buildup.
e. The walls and floors adjacent to the 2-compartment wash sink in the Egg Noodle room had apparent yellow and brown buildup.
Your response stated that you cleaned the walls and ceilings above the rice stick noodle soak tanks and wash tank area and that you will inspect them (b)(4) and document the inspection. Further, you provided a photograph of this area. You also indicated that you will develop proper cleaning procedures for the ceiling and walls and will obtain a quote for the floors in the production area. We cannot fully assess the adequacy of your corrective actions because you have not provided documentation such as your cleaning procedures or records, other than the photograph mentioned above, documenting implementation. (b)(5).
6. You did not properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant, as required by 21 CFR § 117.20(a)(1). Specifically, the following were observed:
a. The exterior facility walls had an over-growth of vegetation. Specifically, on the exterior wall containing the pedestrian door and loading dock door of the Egg Noodle production room, there was an overgrowth of plants above the pedestrian door, and both doors were left open during employee breaks and production breaks.
b. The uncovered trash bins outside of the facility in the front parking lot contained food waste, and on 5/10/2023, at least 7 birds were eating from scraps around the trash bins.
Your response stated that you removed vegetation and will remove it on (b)(4) basis going forward. You also indicated that you trained employees regarding open doors and proper trash storage and will inspect the trash area (b)(4). Further, you will remove the vegetation and clean the trash storage area as part of your Master Sanitation Schedule. We cannot fully assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records or your Master Sanitation Schedule. (b)(5).
Misbranding Violations
1. Your Egg Noodle (5 lb.) and Pancit Noodle (16 oz./1 lb.) products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the finished product labels fail to declare the major food allergen “wheat” as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, your Egg Noodle (5 lb.) and Pancit Noodle (16 oz./1 lb.) products are manufactured using enriched flour, which contains “wheat.”
2. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.), Steamed Chow Mein (14 oz.), and Rice Noodle (16 oz./1 lb., 2 lb., 5 lb.) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label by its common or usual name, as required by 21 CFR 101.4. For example:
a. Egg Noodle (5 lb.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
iii. The product label declares “fresh eggs” while your product formulation indicates the product is manufactured using (b)(4).
iv. The product formulation lists both (b)(4) flour and (b)(4) wheat, neither of which are declared in the ingredient statement.
v. The percent declaration for “potassium carbonate” in the ingredient list is not declared in accordance with 21 CFR 101.4(e).
b. Pancit Noodle (16 oz./1 lb.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
iii. The product formulation indicates the Pancit Noodle product is manufactured using (b)(4), which is not declared on the product label.
iv. The percent declaration for “potassium carbonate” in the ingredient list is not declared in accordance with 21 CFR 101.4(e).
v. The ingredient “(b)(4)” is not declared in accordance with 21 CFR 101.4(b)(14).
c. Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.)
i. The product label declares “Enriched Rice,” which is a standardized food under 21 CFR 137.350. However, the product label fails to include the required sub-ingredients for “enriched rice.”
ii. The product formulation indicates the Rice Stick Noodle product is manufactured using (b)(4) and (b)(4) none of which are declared on the product labels.
iii. The ingredient “(b)(4)” is not declared in accordance with 21 CFR 101.4(b)(14).
iv. The label for the 16oz/1 lb. Rice Stick Noodle lists “contains (b)(4) products,” which is also not a common or usual name of an ingredient.
d. Rice Noodle (16 oz./1 lb. and 5 lb.)
i. The product label declares “Enriched Rice,” which is a standardized food under 21 CFR 137.350. However, the product label fails to include the required sub-ingredients for “enriched rice.”
ii. The product formulation indicates the Rice Noodle products are manufactured using (b)(4) and (b)(4), which are not declared on the Rice Noodle (16 oz./1 lb., 2 lb., 5 lb.) product labels.
iii. The product labels declare “potato starch” which is not listed as an ingredient on the product formulation.
e. Steamed Chow Mein (14 oz.)
i. The product label declares “Artificial Color FD&C Yellow #5;” however, according to our inspection, your firm uses “(b)(4),” which is a multi-component ingredient that includes (b)(4) and (b)(4). The product label fails to declare the sub-ingredients of the (b)(4) food color, as required by 21 CFR 101.4(b)(2).
ii. The product formulation indicates the Steamed Chow Mein product is manufactured using (b)(4), which is not declared on the product label.
iii. The product label declares “Enriched Flour,” which is a standardized food under 21 CFR 137.165. However, the product label fails to include the required sub-ingredients for “enriched flour.”
3. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), Rice Noodle (5 lb.), and Rice Stick Noodle (16 oz/1 lb.) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in accordance with the requirements in 21 CFR 101.9. For example:
a. Your Egg Noodle (5 lb.) and Rice Stick Noodle (16 oz./1 lb.) product labels do not include the following required information: Total Sugars, Added Sugars, Potassium, and Vitamin D, in accordance with 21 CFR 101.9(c). The labels also include a declaration of “Calories from Fat” which is no longer permitted in the updated nutrition facts label (NFL), and the footnote is not in accordance with 21 CFR 101.9(d)(9).
b. Your Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), and Rice Noodle (5 lb.) product labels fail to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b)]. The Pancit and Steamed Chow Mein product labels declare serving sizes of 1 oz. (28g), and the Rice Noodle (5 lb.) label declares 10 oz.; however, the appropriate RACC for noodles is (b)(4), and (b)(4), with a label statement of 2 oz. (56g/visual unit of measure). Therefore, all nutrient amounts are incorrectly declared.
4. Your Egg Noodle (5 lb.) product is misbranded within the meaning of 403(g) of the Act [21 U.S.C. 343(g)]. The product is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the Act and the food does not appear to conform to such definition and standard, in accordance with 21 CFR 139.150. Specifically, your Egg Noodle product contains ingredients, such as FD&C Yellow #5, that are not optional ingredients for this food. See comments below for additional information.
5. Your Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.), Steamed Chow Mein (14 oz.), Rice Stick Noodle (16 oz/1 lb., 5 lb., 10 lb.), and Rice Noodle (5 lb.) products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)]. If a label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear in the foreign language, as required by 21 CFR 101.15(c)(2). For example, the Nutrition Facts labels must be declared in all languages.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Additional Comments
You did not identify and evaluate the hazard of contamination with environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture RTE noodles such as Fresh Rice Noodle and Rice Stick Noodle which are exposed to the environment while they are (b)(4) sliced, packaged, and (b)(4) step. If you identify environmental pathogens as a hazard requiring a preventive control, you are required to implement preventive controls, such as sanitation controls, to provide assurances that this hazard will be significantly minimized or prevented (see 21 CFR 117.135(c)(3)). Further, if contamination with an environmental pathogen is a hazard requiring a preventive control, you must conduct environmental monitoring to verify that your controls are effective (see 21 CFR 117.165(a)(3)).
You did not identify and evaluate the hazard of vegetative pathogens associated with your ingredients and survival of your (b)(4) process as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture RTE noodles such as Fresh Rice Noodle and Rice Stick Noodle products.
Please refer to “CPG Section 505.400 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles (Labeling)” regarding FDA’s policy regarding naming this product. Under this CPG, we do not object to “Oriental-style noodles” being labeled as “noodles,” when a descriptor or qualifying term precedes the term “noodle.”
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent electronically to: orahafwest5firmresponses@fda.hhs.gov.
Otherwise, a hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations West - Division 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number, CMS 659663, when replying. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at clarice.ahn@fda.hhs.gov, or 510-337-6854.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations - West Division 5
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