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WARNING LETTER

Reference #678557

Dear Mr. Pu Wen Wang:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Donggang Wanrui Food Co., Ltd., located at No. 183 Huancheng Dajie, Donggang, Dandong, Liaoning 118300, China on January 22, 2024. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We received your response via email on February 19, 2024. Your response included a “(b)(4)” explaining the “(b)(4) and corrective actions” for each of the noted FDA observations but did not include supporting documents or a date when you estimated providing corrective actions.

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 raw frozen small octopus and raw frozen cut crab 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 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.

Your significant deviations are as follows:

1) You did not implement the monitoring or recordkeeping procedures listed in your HACCP plans for raw frozen small octopus and raw frozen cut crab, to comply with 21 CFR 123.6(b). Specifically,
  a) You did not follow your monitoring procedures for your identified Acquisition of (b)(4) Step critical control point (CCP1), which requires your firm to maintain receiving records by collecting fishing tags and fisherman’s license for each incoming shipment of raw octopus and raw crab to control the hazards of natural marine toxins and environmental contaminants, respectively. Your firm was unable to provide receiving records for raw materials received in 2023, which were subsequently used to produce (b)(4) batch of raw frozen cut crab and (b)(4) batches of raw frozen small octopus, which were delivered to your customer, (b)(4), who in turn shipped the products to the USA.
  b) You did not implement the recordkeeping procedures listed in your HACCP plans for raw frozen small octopus and raw frozen cut crab. During the inspection you provided our investigator with production records for (b)(4) batches of raw frozen small octopus and (b)(4) batches of raw frozen cut crab for the year 2022. However, these records were created the week FDA preannounced the inspection.

2) You must conduct or have conducted a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plans for raw frozen small octopus and raw frozen cut crab do not list the food safety hazard of allergens. Specifically, your firm produces frozen crab (crustacean) and monkfish (finfish) for the USA market. Both species are considered major food allergens and must be addressed in your HACCP plan(s). Your plan(s) should identify critical control points which ensure that products consisting in whole or in part of crab or monkfish are properly labeled to comply with the Food Allergen Labeling and Consumer Protection Act of 2004.

3) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) and maintain records of your observations as required by 21 CFR 123.11I. Those sanitation monitoring records must include observations that are entered on the records at the time they are observed to comply with 21 CFR 123.9(a)(4). Specifically, your firm provided our investigator with daily sanitation monitoring records from March 2023 – November 2023. However, according to your firm’s management, these sanitation monitoring records were not created concurrently but were instead fabricated in 2024 after the FDA pre-announced the current inspection on January 16, 2024.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, 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 plan, 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 corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Furthermore, failure to adequately address this matter may lead to 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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.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 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 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: Giselle Jordan, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (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 Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #678557 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition