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  5. Chaohu Daxin Foodstuffs Co., Ltd. - 700829 - 02/03/2025
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WARNING LETTER

Chaohu Daxin Foodstuffs Co., Ltd. MARCS-CMS 700829 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Gan Shidong
Recipient Title
President
Chaohu Daxin Foodstuffs Co., Ltd.

Zhegao Town
Chaohu Shi
Anhui Sheng, 238062
China

gary2680@qq.com
Issuing Office:
Human Foods Program

United States

February 3, 2025

WARNING LETTER

Re: CMS 700829

Dear Mr. Gan Shidong,

On July 22-23, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, located at Zhegao Town, Chaohu, Anhui, 238062, China. During our inspection of your facility, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21 CFR 117. At the conclusion of the inspection, FDA investigators issued an FDA Form 483, Inspectional Observations. You provided responses to the inspection on August 27, 2024, describing corrective actions taken by your firm. Our evaluation of your response revealed it was not adequate, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your ready-to-eat (RTE) cooked crawfish products, are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the June 2022 Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant violations are as follows:

1. You must have a HACCP plan that at minimum lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as the “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP Plan for Frozen Cooked Crayfish Tailmeat product lists critical limits that are not adequate to control the identified food safety hazards. Specifically:

a. At the “(b)(4)” critical control point (CCP), the critical limit of “(b)(4) temperature: (b)(4)°C; Critical limit (CL): (b)(4) temperature (b)(4)°C; (b)(4) machine (b)(4)HZ.” is not adequate to control pathogenic bacteria survival through cooking. FDA recommends you establish critical limits for the minimum or maximum values for the critical factors established by a scientific study, which may include length of the cook cycle, speed of the belt for a continuous cooker, temperature of the steam or water used for cooking, initial temperature of the product, and any other critical factors that affect the rate of heating the product. Alternatively, you may establish a value for the end product internal product temperature (EPIPT), established by a scientific study.

Furthermore, the monitoring procedures for ensuring appropriate temperature are not adequate because it does not include continuous monitoring of cooking temperature, belt speed after any adjustments, and measurement of crawfish after every raw material lot change. Additionally, the conveyor belt speed frequency values recorded during the cooking process were not consistent with the speed and time values listed in the HACCP plan.

We acknowledge receipt of your response to the FDA-483 received by our office on August 27, 2024. Your response provided a list of scientific literature; however, the literature does not support that your critical limit provides a 6D process. Your firm should validate your cook process to ensure the cook time and temperature are adequate to control pathogens such as Listeria monocytogenes.

b. At the “(b)(4)” CCP, the critical limit of “(b)(4)” is inadequate because it does not address chemical contaminants such as pesticides.

Furthermore, you failed to implement your monitoring procedures of reviewing the supply certificate for exported crawfish for each batch received when you did not have supply certificates for seven of the suppliers of crawfish for batch #(b)(4).

We acknowledge receipt of your response to the FDA-483 received by our office on August 27, 2024. Your response provided a certificate from the Anhui Province Fisher Association that the live crawfish supplied from your supplies come from the Zhegao Town, Chaohu city’s safe freshwater areas. This certification is not adequate because it does not address the standards by which these areas are safe, nor do they address established United States federal tolerance and action levels.

Your response also provided a test report on an intact sample of (b)(4)g of raw material crawfish for analysis conducted on July 29 through August 2, 2024. It is unclear whether this sample meets FDA’s recommendation for verification procedures, which includes the collection of a representative number of samples of the raw material, in-process product, or finished product.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 117 Subpart B, to comply with 21 CFR 123.11(b). However, your firm did not monitor condition and cleanliness of food contact surfaces and protection of food and food contact surfaces from adulteration, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 117 Subpart B, as evidenced by:

a. On July 22, 2024, the white conveyor belt that comes into contact with RTE cooked crawfish was observed with multiple cracks, cuts and crevices. The same conveyor belt was observed with heavy colored stains and dark patches after cleaning.
b. On July 22, 2024, condensate build-up was observed and dripping from the surfaces of the air conditioning unit in the peeling production workshop onto food contact surfaces during work in progress, from the surface of the air conditioning unit inside the temporary walk-in cooler onto uncovered baskets of RTE defrosted cooked crawfish semi-finished product.

We acknowledge receipt of your response to the FDA-483 received by our office on August 27, 2024. Your response include photographs of the conveyor belt with new parts, but the adjacent conveyor belt appears to still be stained. Additionally, we cannot fully evaluate your corrective actions to condensate drip because you did not provide records, such as training or sanitation records, to demonstrate your change in practices.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you doing to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your Hazard Analysis and HACCP plan for your RTE cooked crawfish products, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrective actions within 15 working days, you should explain the reason for the delay and state when you will correct any remaining violations. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Elodie X. Tong-Lin, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Elodie X. Tong-Lin via email at: Elodie.Tong-Lin@fda.hhs.gov. Please include reference CMS #700829 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A.
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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