This is a lengthy Warning Letter, but here are the highlights:
1. The firm did not identify and with that, have preventive controls in place for environmental pathogens including Listeria. And as proof to this point, FDA conducted swabbing and found Listiera.
"FDA laboratory analysis of environmental sample 1216621 collected on August 9, 2023, from various areas in your processing facility during production found that eight (8) out of 111 swabs were confirmed positive for L. monocytogenes. These positive swabs were recovered in all areas of your facility including where the RTE meals are packaged, exposed to the environment, and (b)(4) by employees. Specifically, L. monocytogenes was found on a surface above your (b)(4) sink used to store utensils near the noodle and rice (b)(4) in the production area, on the wheels of multiple carts and racks located in the production area and packaging room, and the floor in the production area."Interesting is that USDA testing had found Listeria.
"In addition, this is not the first time L. monocytogenes had been found in your facility. L. monocytogenes has also been recovered in samples collected by USDA FSIS, as follows:This is an important point that a Preventive Controls approach forces the firm to do more in terms of controlling environmental pathogens.
May 18, 2023, your finished product, RTE Chicken Lo Mein. This product was held and not distributed to the public.
August 30, 2023, non-food contact environmental swabs collected from your facility."
2. The firm did not identify allergens as a hazard requiring a Preventive Control even though there were plenty areas for cross contact and did not follow thier own procedures for preventing allergen cross contact.
3. The firm did not recognize vegetative pathogens such as Salmonella in the raw materials, and with that, did not establish cooking as a kill step (although in making the product, they probably well exceeded the needed level. Also, did not identify mycotoxins in wheat and peanuts.
4. Did not control chilling step.
"Your practice for chilling RTE fried rice is to spread cooked rice on a tray, which is then placed into a rolling rack. You continue to cook batches, fill trays, and load trays onto the rack to cool. Throughout the inspection, the investigator noted the ambient air temperature of the production room to be (b)(4)°F or higher."5. Plenty of GMP issues including employees not washing hands, poor facility cleanliness, improper cleaning of utensils, and improper use of high pressure hoses (which is a huge issue when you have Listeria contamination in the plant).
6. Misbranding - numerous issues.
7. Reportable Food Registry - Failure to report.
"Specifically, you informed our investigator that on April 3, 2023, your customer conducted a recall on LuLu Chinese Express brand Korean Noodles with Vegetables with a Sell By date of April 11, 2023, due to an undeclared major food allergen, egg. Therefore, you became aware that the affected batches of this food contained undeclared egg on or about April 3, 2023, but you have not submitted a report to the Reportable Food Registry as of March 13, 2024".
Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jx-restaurants-inc-669669-03192024
JX Restaurants, Inc.
MARCS-CMS 669669 — MARCH 19, 2024
Recipient:
LuHua Lu, Owner
Zun Xing Li, Owner
JX Restaurants, Inc.
64 Weldon Pkwy
Maryland Heights, MO 63043-3202
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
March 19, 2024
WARNING LETTER
CMS # 669669
Dear Mrs. Lu and Mr. Li:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) rice and noodle-based meals manufacturing facility, located at 64 Weldon Pkwy, Maryland Heights, MO from August 8, through September 1, 2023. Your facility also manufactures RTE rice and noodle-based meals under the jurisdiction of the United States Department of Agriculture, Food Safety Inspection System (USDA FSIS). During our inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule) Title 21, Code of Federal Regulations Part 117 (21 CFR Part 117). FDA also collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and analytical results for samples collected from your production environment, we have determined your RTE rice and noodle-based meal products 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 have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. It is a prohibited act under section 301(uu) of the Act, for the owner, operator, or agent in charge of such a facility to not comply with the Act or subpart C, D, E, or F of part 117. You may find the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive controls for Human Food and FDA’s regulations through link in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility. We received your email responses dated October 12, 14, and 15, 2023, and address the details of your responses below. Based on our review of the inspectional findings and the responses 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.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. You did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE rice and noodle-based products (including Vegetable Fried Rice and Shrimp Fried Rice), as required by 21 CFR 117.130(a)(1). Specifically:
a. Your hazard analysis evaluated the hazard of recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) but did not identify it as requiring a preventive control, as required by 21 CFR 117.130(a)(1). Your facility manufactures RTE rice and noodle-based products which are exposed to the environment after cooking prior to packaging. Your employees (b)(4) the food and the packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).
Your HACCP plan states exposure to L. monocytogenes at the post lethality step where product is exposed to the environment is controlled by your prerequisite program for sanitation and time-temperature control at storage. Your prerequisite program is identified as your sanitation standard operating procedures (SSOPs) and storage SOP for “time and temperature GMPs.” Your cleaning and sanitation procedures state you will develop a master cleaning and sanitation schedule that will include the equipment/location being cleaned, frequency, person(s) responsible, and description or SSOP. It also states that “cleaning and sanitation practices are monitored and verified using (b)(4) swabs during post-cleaning/sanitation. Additionally, the cleanliness of the facility is visually monitored during our (b)(4) GMP inspections.” However, you informed our investigator that you do not collect (b)(4) swabs. As documented through the L. monocytogenes findings at your facility during the inspection, your prerequisite program is not adequate to ensure that you are significantly minimizing or preventing the hazard of the environmental pathogen L. monocytogenes.
Listeria monocytogenes in your facility:
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of environmental sample 1216621 collected on August 9, 2023, from various areas in your processing facility during production found that eight (8) out of 111 swabs were confirmed positive for L. monocytogenes. These positive swabs were recovered in all areas of your facility including where the RTE meals are packaged, exposed to the environment, and (b)(4) by employees. Specifically, L. monocytogenes was found on a surface above your (b)(4) sink used to store utensils near the noodle and rice (b)(4) in the production area, on the wheels of multiple carts and racks located in the production area and packaging room, and the floor in the production area.
In addition, this is not the first time L. monocytogenes had been found in your facility. L. monocytogenes has also been recovered in samples collected by USDA FSIS, as follows:
May 18, 2023, your finished product, RTE Chicken Lo Mein. This product was held and not distributed to the public.
August 30, 2023, non-food contact environmental swabs collected from your facility.
Whole Genome Sequencing (WGS) analysis was conducted on the above referenced L. monocytogenes isolates obtained from your facility or product manufactured in your facility. Based on the results of the WGS analysis, ten (10) isolates represent two strains of L. monocytogenes:
Strain 1 includes seven (7) isolates from the environmental swabs collected by FDA on August 9, 2023, and one (1) isolate from non-food contact environmental swabs collected by FSIS on August 30, 2023. Strain 1 also matches a clinical isolate, indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility.
Strain 2 includes one (1) isolate from the environmental swabs collected by FDA on August 9, 2023, and one (1) isolate from the finished product sample collected by USDA FSIS on May 18, 2023.
The presence of the same strain of L. monocytogenes over an extended period of time after multiple cleaning and sanitation activities is indicative of a resident pathogen in your facility. We advised you of these WGS results via a conference call on October 19, 2023.
The presence of L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility so as to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive, and to take such corrective actions as are necessary to eradicate the organism.
In addition, your written response outlines the corrective actions you plan to take and those you have implemented, including (b)(4) and training employees in HACCP. You have also implemented a Master Cleaning and Sanitation schedule to include changing your cleaning and sanitizing chemicals, and routine and deep cleaning of your walk-in coolers, floors, knobs, cars, wheels, and trays. These activities will be documented on your Master Cleaning and Sanitation schedule form. You have also installed (b)(4) at the front and back entrance of the building to prevent potential pathogen spread in the facility and have committed to color coding and segregating aprons and towels between the cooking and packaging area. However, you have not conducted comprehensive investigation to identify harborage sites, nor have you completed a deep clean of the processing facility (i.e., extensive disassembly of equipment and facility components to clean potential harborage sites that are otherwise inaccessible during normal, (b)(4) sanitation). Furthermore, you have not reanalyzed your hazard analysis and food safety plan to identify the hazard of recontamination with environmental pathogens as a hazard requiring a preventive control. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
b. Your hazard analysis evaluated the hazard of allergen cross-contact but did not identify it as requiring a preventive control, as required by 21 CFR 117.130(a)(1). Your facility manufactures RTE rice and noodle-based products which contain allergen ingredients (e.g., shrimp, eggs, and peanut) that are manufactured on shared equipment on (b)(4) and (b)(4) by your employees. A knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control (i.e., sanitation controls or other food allergen controls). Food allergen controls include procedures, practices, and processes to control food allergens. These controls must ensure the protection of food from allergen cross-contact, including during storage, handling, and use, and must be adequate to significantly minimize or prevent hazards such as allergen cross-contact (see 21 CFR 117.135(c)(2) and (c)(3)).
Your hazard analysis identifies allergens as a hazard but states the hazard does not require a preventive control because the hazard is controlled through prerequisite programs, Allergen Program, Sanitation SOP, and GMP Procedures. Your procedure titled, “PRO-019-Allergen Management Procedures,” states you will use sanitary equipment and utensils, ensure appropriate cleaning and sanitation practices are followed, and “monitor cleaning and sanitation practices using (b)(4) swabs or other cleaning verification methods before/after cleaning and sanitation.” However, you are not implementing these procedures. You confirmed you do not have a master cleaning schedule and are not using (b)(4) swabs or other cleaning verification methods as required by your procedure. Further, cross contact with allergens was observed during this inspection. An employee that was handling shrimp was observed using the same gloved hand to touch non-shrimp/allergen ingredients and commonly used utensils that would be incorporated into meals that did not contain shrimp.
In your written response, you committed to storing ingredients on separate racks in your storage area, and assigning specific tables, containers, and ingredients for the Shrimp Fried Rice. You also committed to cleaning all tables and trays used during the production of Shrimp Fried Rice and (b)(4). You affirmed that the cooking of noodles and fried rice was separate and different trays would be used. In addition, you (b)(4). Finally, you committed to make sure each product label was verified to contain all the ingredients in the product. The adequacy and implementation of these corrective actions will be assessed during a future inspection. However, we note that you have not reanalyzed your hazard analysis and food safety plan to identify the hazard of allergen cross-contact as a hazard requiring a preventive control.
2. You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE rice and noodle-based products (including Vegetable Fried Rice and Shrimp Fried Rice), as required by 21 CFR 117.130(a)(1).
a. You did not identify and evaluate the hazard of bacterial pathogens as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE noodle-based meals that (b)(4). The (b)(4) (e.g., (b)(4), respectively) are (b)(4) and do not receive a kill-step on site. A knowledgeable person manufacturing/processing food in your circumstances would identify vegetative bacterial pathogens as a hazard requiring a preventive control in these ingredients. Therefore, you are required to identify and implement preventive controls for the hazard of bacterial pathogens (such as Salmonella) in these ingredients used in manufacturing. Moreover, a facility that identifies RTE raw materials, which do not receive a kill-step at the facility where they are used as ingredients, but which require a supply-chain control, must establish and implement a risk-based supply-chain program for those raw materials or implement a validated lethal process at the facility.
b. You did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE noodle-based meals containing wheat flour and peanuts, which has 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 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 such as onsite audits, sampling and testing of the raw material, review of the supplier’s relevant food safety records, and other appropriate supplier verification activities (see 21 CFR 117.410).
Your procedure titled, “PRO-017-Supplier Approval Program” requires all suppliers “to provide product specifications and various certificates or documentation that verifies they meet our company’s safety/quality requirements and governmental requirements.” However, during the inspection, you stated you had only approved (b)(4) who appears to be a distributor. Note that part 117 defines a “supplier” as the establishment that manufactures/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature. (21 CFR 117.3). Part 117 defines a “supply-chain-applied control” as a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. (21 CFR 117.3). Furthermore, supplier approval by itself does not verify that supplier control of the hazard is operating as intended on an ongoing basis. Therefore, as evidenced by your lack of ingredient testing or other adequate assurance from your suppliers, you did not implement adequate supply chain controls to ensure that the RTE ingredients used in the production of your RTE products are not contaminated with pathogenic bacteria or mycotoxins, as required by 21 CFR 117.135(a)(1).
Despite your indicating that you determined that a supply-chain preventive control is not required, in your e-mail response dated October 12, 2023, you stated you would “rigorously enforce” your PRO-017-Supplier Approval Program, including treatment steps for hazardous ingredients with a known chemical or biological hazard. You stated you would take appropriate treatment steps prior to their inclusion in the RTE finished product. It is unclear what verification activities you will utilize to demonstrate the biological or chemical hazards of your ingredients are being controlled. Furthermore, if you control vegetative bacterial pathogens in a raw material or other ingredient via a supply-chain program, note that L. monocytogenes and Salmonella are hazards that can cause serious adverse health consequences or death. Therefore, an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).
3. You did not implement your 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 (21 U.S.C. §§ 342 or 343(w)), as required by 21 CFR 117.135(a)(1). Specifically:
Your facility manufactures RTE-noodle non-meat meal entrees (e.g., Vegetable Fried Rice which contains cooked and cooled large batches of rice (raw), shell eggs (refrigerated), fried rice, and vegetables (cabbage, white onions, broccoli, and carrots)). Your hazard analysis identifies the hazard of bacterial growth and/or toxin formation due to lack of time/temperature control as a hazard requiring a preventive control at the Chilling step (CCP #(b)(4)). Per CCP #(b)(4), product temperatures at the chilling step are to be documented on the record titled, “HACCP (b)(4) Temperature Log.” Your Process Preventive Control program requires an internal temperature of (b)(4)°F to < (b)(4)°F in less than (b)(4) or above, and from (b)(4)°F to < (b)(4)°F within (b)(4) (critical limit). This is to be monitored by a designee placing a product thermometer in the (b)(4) ((b)(4) is defined as (b)(4)) and holding it in the (b)(4). However, FDA’s review of your records noted that you do not keep records of chilling the ingredients to be added to non-meat RTE meals. In addition, you neither have a procedure for appropriately identifying racks of actively cooling product, nor does your record include an identifier for each line item of product.
Furthermore, you are not controlling the hazard of bacterial growth and/or toxin formation due to lack of time/temperature control at the chilling step. Your practice for chilling RTE fried rice is to spread cooked rice on a tray, which is then placed into a rolling rack. You continue to cook batches, fill trays, and load trays onto the rack to cool. Throughout the inspection, the investigator noted the ambient air temperature of the production room to be (b)(4)°F or higher.
On August 16, 2023, at approximately 11:27 am, the ambient air temperature, taken with an FDA calibrated thermometer, was 80°F. At this time, we followed and documented a rack of fried rice in production that was left to cool for at least 3 and a half hours on the production floor. The fried rice product temperature was (b)(4)°F. This temperature was taken from the top rack of rice that is cooked first and remains at room temperature the longest.
On August 25, 2023, at approximately 1:34 pm, we observed a rack of fried rice in cooler (b)(4) with a production sticker of 8/24. The fried rice product temperature was recorded as 55.4°F using an FDA calibrated thermometer. The production manager stated that the rice product was fried (b)(4) and left to cool (b)(4). Your procedure in your HACCP plan for chilling states Internal temp from (b)(4)°F to less than or equal to (b)(4)°F in less than (b)(4), and from (b)(4)°F to attain less than or equal to (b)(4)°F within (b)(4).
Your response states that you have set up a system to monitor chilling to ensure food is cooled properly and will track the temperatures of the food during the chilling process with the “aim” of cooling from (b)(4)°F to no higher than (b)(4)°F in less than (b)(4), and then from (b)(4)°F to no higher than (b)(4)°F within (b)(4). You committed to using a calibrated thermometer to measure the temperature at the (b)(4) in (b)(4).” You also stated that you would record the temperatures for all the non-meat products. You provided a blank record, (b)(4) Log, where you will record the temperatures. However, you did not provide supporting documentation that you have implemented this preventive control. We will assess the adequacy and implementation of this process preventive control during a future inspection.
Current Good Manufacturing Practice Requirements (Subpart B):
FDA found that 24 of 111 swabs were positive for non-pathogenic species (spp.) of Listeria, including Listeria innocua (22), Listeria welshimeri (1), and Listeria seeligeri (1). The presence of non-pathogenic Listeria species is indicative of insanitation and conditions that are suitable for the survival and/or growth of pathogenic L. monocytogenes. The wide presence of non-pathogenic Listeria spp. further demonstrates that the cleaning and sanitation procedures used in your facility are inadequate. Furthermore, our investigators observed serious deviations from the CGMPS, including:
1. Employees did not wash hands thoroughly when their hands may have become soiled or contaminated, as required per 21 CFR 117.10(b)(3). Specifically, on August 10, 2023, our investigators observed three employees returning to the production room to cook RTE rice and noodles after a break without washing their hands. During production, employees entered and exited the push open doors without washing and or sanitizing their hands and pushed wheeled equipment into and out of the push open doors. Furthermore, one employee proceeded to place his bare hands onto a tray of cooling rice (directly on the rice product) and the handle of the black wheeled cart used to transport RTE food, which was positive for Listeria innocua (L. innocua) on its wheel.
2. You did not maintain your plant in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). L. innocua was found in multiple areas of the production room floor which were observed to be cracked or damaged, as well as on a floor drain. Damaged flooring areas are difficult to clean and present possible harborage areas for microorganisms. The widespread presence of nonpathogenic Listeria spp. on the plant floor is also concerning because your firm uses wheeled carts and racks to move ingredients and RTE food around your facility where the products are exposed to the environment. L. innocua was found on a wheeled cart holding heads and halves of cabbage and racks used to hold trays of RTE crab rangoon.
3. You did not clean and sanitize utensils and equipment in a manner that protects against contamination of food and food contact surfaces, as required by 21 CFR 117.35(a). Our investigators observed the use of a hose with a pressurized nozzle and a pressure washer during cleaning and sanitation. Specifically:
On August 9, 2023, a black hose with a pressurized nozzle was connected to a water supply in the wall with excess hosing stored beneath the ice machine and partially submerged in a black bin also under the ice machine. The nozzle was observed to be in direct contact with the floor. You stated the hose is used during production to spray equipment (e.g., three compartment sink used for cleaning utensils and the dishwasher) and the floors with water. L. monocytogenes was isolated from a swab collected from the bottom sidebar leg of the ice machine near the black bin.
On August 9, 2023, a wheeled power washer was observed near the (b)(4) for RTE vegetables, with the nozzle end touching the floor. L. innocua was isolated from a green and white broom also stored on the floor near the (b)(4). On August 25, 2023, the wheeled power washer was observed stored on the dock with the nozzle touching the floor. You stated the pressure washer is used to spray equipment and the floors and also is rolled outside to spray down rolling equipment.
The use of high-pressure hoses creates overspray and aerosols that can transfer and spread pathogens from the environment to food contact surfaces, and floors are common sources of environmental pathogens such as L. monocytogenes. Wheeling equipment from production areas to outside areas can also introduce environmental pathogens into the production area and transfer the pathogens throughout the facility.
3. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls to minimize the contamination of food, as required by 21 CFR 117.80(c)(2). Our investigators observed uncovered RTE fried rice being held on portable tray rack in the cooler. Condensation was observed on the underside of multiple top bars of the rack being used to hold uncovered RTE fried rice.
In your written responses you provided photographs demonstrating sanitary improvements in your process and facility, including the repair of floor surfaces near cooler (b)(4) and removal of wooden materials from the production area. You also reported that you plan to clean the floors, knobs, carts, wheels, and trays (b)(4) and deep clean (b)(4). Additionally, we acknowledge the photographs demonstrating the installation of (b)(4) handwashing stations, additional signage, and the retraining of employees on proper food hygiene. However, you did not provide information demonstrating you have discontinued the use of high-pressure hoses and are protecting food from condensation. The adequacy of these corrective actions will be evaluated during a future inspection.
Color Additive Labeling:
Your Sister Sister brand and Lulu Chinese Express brand Vegetable Lo Mein products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your Vegetable Lo Mein products are manufactured with “(b)(4) Noodles” manufactured with the declared ingredient, FD&C Yellow No. 5. However, the label for these products fails to declare FD&C Yellow No. 5 in the ingredient statement.
Misbranding:
1. Your Sister Sister brand Crab Rangoon, Sister Sister brand Vegetable Lo Mein, and LuLu Chinese Express brand Vegetable Lo Mein 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 allergens as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergen” as milk, egg, fish, Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils.” A food is misbranded under section 403(w) of the Act 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, as per 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 (e.g., “Whey (Milk)”), except 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:
For the Sister Sister brand Crab Rangoon:
o The “Contains” statement is not placed immediately following or adjacent to the ingredient list in accordance with the requirements in section 403(w)(1)(A) of the Act.
o Although the species of fish and Crustacean shellfish are declared in the ingredient statement, the “Contains” statement declares “fish” and “shellfish.” Such declaration of the allergen food groups in the “Contains” statement are not in accordance with section 403(w)(2) of the Act.
o The source of the “soy” declared in the “Contains” statement is not clear because the Crab Rangoon ingredient list does not declare all the sub ingredients of the imitation crab meat which “Contains” soybean protein. The Crab Rangoon product is made with imitation crabmeat, which lists soybean protein in its ingredient list; however, the Crab Rangoon ingredient list only includes soybean oil.
MSG is declared as part of the “Contains” statement for the LuLu Chinese Express brand Vegetable Lo Mein. MSG is not a major food allergen and is not to be declared as part of a “Contains” statement provided for under 403(w) of the Act.
2. Your Sister Sister brand Crab Rangoon product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the statement of identity does not reveal the material fact that the “crab” ingredient used to make this product is imitation crab meat.
4. Your Sister Sister brand Vegetable Lo Mein, Sister Sister brand Crab Rangoon, Sister Sister brand Shrimp Fried Rice, and Lulu Chinese Express brand Vegetable Lo Mein products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient or sub-ingredient is not declared on the label, as required under 21 CFR 101.4. For example:
Your Sister Sister brand Vegetable Lo Mein product:
o Is manufactured using hoisin sauce and oyster sauce, which are not declared in the ingredient statement as required by 21 CFR 101.4(a)(1).
o The sub-ingredients of these ingredients are not listed as required by 21 CFR 101.4(b)(2).
o All of the sub-ingredients for the egg noodles ingredient are not listed as required by 21 CFR 101.4(b)(2). Specifically, the product label fails to declare the corn starch, soy lecithin, and the colors FD&C Yellow 5 and Yellow 6.
o The vegetable source of the vegetable oil is not listed as required by 21 CFR 101.4(b)(14).
Your Sister Sister brand Crab Rangoon product:
o Threadfish bream is not the common or usual name for any fish.
o Is manufactured using imitation crab meat and the sub ingredients of this ingredient are not declared.
o Is manufactured using cream cheese and the sub-ingredients of this ingredient are not listed as required by 21 CFR 101.4(b)(2).
o The vegetable source of the vegetable oil is not listed as required by 21 CFR 101.4(b)(14).
o If the “garlic oil” ingredient is a multicomponent food, the sub-ingredients must be declared.
Your Sister Sister brand Shrimp Fried Rice is manufactured using the same formulation as the Lulu Chinese Express brand Shrimp Fried Rice but the same ingredients are not listed for the Sister Sister brand product. Specifically:
o The product is manufactured using mushroom flavored soy sauce which is not identified on the Sister Sister brand label as required by 21 CFR 101.4(a)(1).
o The sub-ingredients of that multi-component ingredient as well as all of the sub-ingredients of the (b)(4) brand Soy Sauce are not listed as required by 21 CFR 101.4(b)(2).
o The vegetable source of the vegetable oil used is not listed as required by 21 CFR 101.4(b)(14).
o The label lists two ingredients which you state are not used, distilled vinegar and rice wine.
Your Lulu Chinese Express brand Vegetable Lo Mein:
o All of the sub-ingredients for the egg noodles are not listed as required by 21 CFR 101.4(b)(2). Specifically, the product label fails to declare the corn starch, soy lecithin, and the colors FD&C Yellow 5 and Yellow 6.
o The vegetable source of the vegetable oil is not listed as required by 21 CFR 101.4(b)(14).
o If the “red chili oil” ingredient is a multicomponent food, the sub-ingredients must be declared.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
5. Your Sister Sister brand Vegetable Lo Mein, Sister Sister brand Crab Rangoon, Sister Sister brand Shrimp Fried Rice, and Lulu Chinese Express brand Vegetable Lo Mein products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. Specifically:
The Nutrition Facts label (NFL) on the Sister Sister brand products do not use the current format, nutrients, etc. defined in 21 CFR 101.9.
The Lulu Chinese Express brand product does not include an NFL and does not appear to have filed for an exemption from the requirement by filing an annual filing for those products which may qualify under 21 CFR 101.9(j)(18)(ii).
6. Your Sister Sister brand Crab Rangoon product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the statement of identity is not appropriately descriptive in that it does not indicate that the “crab” ingredient used to make this product is imitation crab meat.
7. Your Lulu Chinese Express brand Vegetable Lo Mein product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label fails to bear the place of business of the manufacturer, packer, or distributor.
8. Your Sister Sister brand Vegetable Lo Mein and Lulu Chinese Express brand Vegetable Lo Mein products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains artificial coloring, but fails to bear labeling stating that fact. Specifically, your products are manufactured with egg noodles which are labeled to have FD&C Yellow 5 and Yellow 6 as ingredients; however, the products do not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).
Reportable Food Registry
Furthermore, your firm failed to report a Reportable Food to the Reportable Food Registry within twenty-four hours of determining that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by Section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)]. Specifically, you informed our investigator that on April 3, 2023, your customer conducted a recall on LuLu Chinese Express brand Korean Noodles with Vegetables with a Sell By date of April 11, 2023, due to an undeclared major food allergen, egg. Therefore, you became aware that the affected batches of this food contained undeclared egg on or about April 3, 2023, but you have not submitted a report to the Reportable Food Registry as of March 13, 2024.
The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by the FDA to target limited inspection resources to protect the public health. It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” (b)(3)(A).
We received your email on or about September 29, 2023, written to advise the FDA that you have conducted a recall on this product as well as your corrective actions taken as a result of the recall. However, your response does not adequately address reporting of “Reportable Foods” to the FDA. You do not address how you will ensure that your reporting duties are satisfied. Further, the corrective actions you describe do not provide assurances that existing or future labels will be reviewed or written in a manner that prevents misbranding, as several of the charges, including the section 403(w) charge, listed in this letter demonstrate.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or 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.
We also offer the following comments:
We note that your Sister Sister products are currently identified as having “2” servings per container. We suggest that, when revising the NFLs, you also evaluate the servings per container within the meaning of 21 CFR 101.9(b)(8).
In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The Sister Sister brand labels do not include the street address.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 fifteen (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 FD&C Act, include your reasoning and any supporting information for our consideration.
Please send your firm’s response to Kevin A Beavers, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Beavers at 417-873-9455 Ext 102.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods West Division II
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