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May 9, 2022

WARNING LETTER
 

Reference #630966

Dear Mr. Jian Guo Zhou:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Zhoushan Haichang Co. Ltd located at Pingyang Industrial Zone, Shenjiamen, Putuo District Zhoushan, Zhejiang, 316101, China on March 3 and 4, 2022. During the 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). We acknowledge your email response dated, March 22, 2022, to the FDA 483, Inspectional Observations issued to you on March 4, 2022.

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 frozen (cut), swimming 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 and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant deviations are as follows:
1. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for Frozen (cut) swimming crab does not list the critical control point of labeling to control the food safety hazard of sulfites. Your current plan lists a (b)(4) critical limit for sulfites that allows acceptance of crabs with residues up to (b)(4) ppm. FDA requires the declaration of the presence of sulfites when sulfite residues are 10 ppm or greater on labels and a critical control point to assure accurate labeling. If you choose not to declare the presence of sulfites on your labels and establish a critical control point in your plan, FDA recommends adjusting your current receiving critical limit to exclude raw material swimming crabs with residues of 10ppm or greater.

2. You must conduct or have conducted for you 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 plan does not list the food safety hazard of allergens associated with the frozen cut swimming crab (crustacean).

3. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)‐(8), to comply with 21 CFR 123.11(b). The firm failed to monitor with sufficient frequency the 8 key areas of food safety as demonstrated:
a. Safety of water as required by 21 CFR 123.11(b)(1). During the inspection, there was debris and residue in water use to produce ice.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking 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.

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 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.

You should direct your written reply to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS‐608), Division of Enforcement, College Park, Maryland 20740‐3835. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at [email protected]. Please reference CMS #630966 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

Amy Barringer
Acting Deputy Director
Office of Compliance
Center for Food Safety and Applied Nutrition