- Did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured,
- Did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. The company processes products containing different allergen profiles on the same equipment (e.g., bowl mixer, noodle sheet maker, sheet rollers, former/cutter, and finished product conveyor) and using shared utensils on the same production day.
- Did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The company manufactures Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products, which contain wheat flour as an ingredient. Wheat flour has been associated with mycotoxins such as deoxynivalenol (DON)
- Did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Product is manufactured with processing equipment (e.g., (b)(4) noodle cutters) with metal-to-metal contact. The company does not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
- Misbranding the finished product labels fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act.
Alfred Louie, Inc.
MARCS-CMS 680624 — September 11, 2024
Mr. Michael Louie, President
Mr. Gordon Louie, Secretary
Alfred Louie, Inc.
4501 Shepard St.
Bakersfield, CA 93313
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
September 11, 2024
WL 680624
Dear Messrs. Louie:
The Food and Drug Administration (FDA) conducted an inspection of your sprouting operation and noodle manufacturing facility, located at 4501 Shepard St., Bakersfield, CA 93313 from January 2 through February 20, 2024. The inspection revealed serious violations of the of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).1 Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. Based on FDA’s inspectional findings, we have determined that your raw fresh noodle products are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. 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)]. You may find the Act and further information about the Act and FDA regulations through links on FDA's website at http://www.fda.gov.
At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations (FDA 483), listing the deviations found at your facility. We received your response to the FDA 483 via email on March 12, 2024. After reviewing the inspectional findings and your response to the observations listed in the FDA 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address the details of your response below.
A. Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. 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, as required by 21 CFR § 117.130(a). Specifically,
a) You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures various noodle products that contain allergens (such as wheat and egg). You process products containing different allergen profiles on the same equipment (e.g., bowl mixer, noodle sheet maker, sheet rollers, former/cutter, and finished product conveyor) and using shared utensils on the same production day. 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)).
You do not have appropriate controls in place for the hazards of allergen cross-contact and undeclared allergens. For example:
i. Your Food Safety Consultant informed the FDA investigators that the noodle manufacturing line is composed of custom manufacturing parts (e.g., (b)(4)) that cannot be taken apart and adequately cleaned. You use this equipment to manufacture both Pan Fry Fresh Noodles (containing wheat and eggs) and Deep Fry Fresh Noodles (containing only wheat allergen).
ii. During our inspection, FDA investigators observed that your Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products are manufactured using enriched flour, which contains wheat; however, the finished product packaging/labels do not declare the major food allergen wheat. As a result, on January 16, 2024, your firm recalled these products produced between January 3, 2024 through January 15, 2024.
b) You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. You manufacture Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products, which contain wheat flour as an ingredient. Wheat flour has been associated with mycotoxins such as deoxynivalenol (DON). 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.
c) You did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products in processing equipment (e.g., (b)(4) noodle cutters) with metal-to-metal contact. We note that you do not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
Note that 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).
In your response, you stated that a Food Safety Plan for the Noodle Line for the manufacturing of raw pan fry fresh noodles and raw deep fry fresh noodles will be developed and completed by August 31, 2024, and that a Supplier Approval Program will be developed by September 30, 2024. You stated that the “FS Plan will include a hazard analysis, an allergen program, methods, and procedures for products manufactured with and without egg, cleaning and sanitizing procedures, record forms and logs, verification procedures, corrective actions, etc.” You additionally stated the entire noodle line has been removed from the facility to be refurbished, with an estimated completion date of June 30, 2024, and that training will be provided once the food safety manual is completed, and the noodle line is back in operation. Further, you have discontinued the use of the noodle box (i.e., finished product packaging/labels) and are still in the process of having a new box (i.e., finished product packaging/labels) made. You are also in the process of obtaining a quote for the purchase of a metal detector to address the metal-to-metal contact. However, you did not address whether you plan to continue manufacturing noodle products after completion of the refurbishment and prior to completion and implementation of your Food Safety Plan. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
B. Misbranding Violations
Review of your finished product labels reveals that they are misbranded for the following reasons:
1. Your Pan Fry Fresh Noodle and Deep Fry Fresh Noodle 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 accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, your noodle products did not declare the allergen of wheat.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” 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 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 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 (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)].
2. Your Pan Fry Fresh Noodles and Deep Fry Fresh Noodles 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 the common or usual name of each ingredient is not declared on the label, as required under that provision and 21 C.F.R. § 101.4. Specifically:
These products are manufactured using an enriched flour comprised of multiple ingredients, such as niacin, reduced iron thiamine mononitrate, riboflavin, and folic acid. Your finished product label fails to list all the enriched flour sub-ingredients in the ingredient statement.
There is no provision within 21 CFR 101.4 for the phrase “Dusted With” in the ingredient list. Further, “not more than 1/10 of 1% of benzoate of soda” is not the common or usual name for “sodium benzoate.” In accordance with 21 CFR 101.4(e), if the percentage of an ingredient is included in the statement of ingredients, it shall be shown in parentheses following the name of the ingredient and expressed in terms of percent by weight.
These products contain FD&C Yellow No. 6 and FD&C Red No. 40; however, these ingredients are not declared on the product label as required under 21 CFR 101.22(k)(1).
These products are manufactured with the ingredient vital wheat gluten; however, this ingredient is not declared on the finished product label.
3. Your Deep Fry Fresh Noodles is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false or misleading because it includes “Egg Whites” in the ingredient statements; however, egg whites are not an ingredient in the product formulation.
4. Your Pan Fry Fresh Noodles and Deep Fry Fresh Noodles are misbranded withing the meaning of section 403(g) of the Act [21 U.S.C. § 343(g)]. The products appear to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.150 for noodle products and 21 CFR 139.155 for enriched noodle products.
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. It is also your responsibility to comply with the Consent Decree of Permanent Injunction entered by the United States District Court for the Eastern District of California on November 20, 2013 in United States v. Louie, Case No. 2:13-cv-02367 and, as noted above, you may receive additional, separate communication from FDA regarding violations that are or may be subject to that decree.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within fifteen (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 complete the correction. 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.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number 680624 when replying.
If you would prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification Number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or 510-337-6870.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
__________________
1 This letter only pertains to violations that do not fall within the scope of the Consent Decree of Permanent Injunction entered by the United States District Court for the Eastern District of California on November 20, 2013 in United States v. Louie, Case No. 2:13-cv-02367. You may receive additional, separate communications from FDA regarding violations that are or may be subject to that decree.
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