- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Sheng Lin
- Hainan Golden Spring Foods Co. Ltd.
No.9, Xingyang 3rd Cross Road
The Industrial Zone of Guilinyang Economic Development Zone
Hainan Sheng, 571127
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
May 4, 2022
Dear Mr. Sheng Lin:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Hainan Golden Spring Foods Co. Ltd. located at No.9, Xingyang 3rd Cross Road, The Industrial Zone of Guilinyang Economic Development Zone, Meilan District, Haikou, Hainan, 571127, China on December 13 – 15, 2021. During that inspection, we found that your firm had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response via email on January 5, 2022. Your response included a revised HACCP plan for your reduced oxygen packaged frozen tilapia fillets, dated December 20, 2021, as well as various monitoring records. However, 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 raw frozen reduced oxygen packed tilapia fillets and whole tilapia G&S (gutted and scaled) 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:
You must implement the monitoring and verification procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4), and (c)(6). However, your firm did not follow monitoring and verification procedures for every lot at the (b)(4) critical control point (CCP1) to control aquaculture drug residues listed in your HACCP plan for raw frozen reduced oxygen packed tilapia fillets, dated March 7, 2021. Specifically,
a. Your production records for finished product lot # (b)(4) ((b)(4)) lists a total of (b)(4) drug residue testing results under the (b)(4) method conducted by your laboratory between August 17 to August 28, 2021. Our investigator reviewed your laboratory’s (b)(4) FC equipment use log and found only (b)(4) tests were run between the same timeframe.
b. Your production records for finished product lot # (b)(4) ((b)(4)) lists a total of (b)(4) drug residue testing results under the (b)(4) method conducted by your laboratory between November 16 to November 26, 2021. Our investigator reviewed your laboratory’s (b)(4) FC equipment use log and found only (b)(4) tests were run between the same timeframe.
Your firm could not explain the discrepancy because your laboratory does not keep sample preparation records. The laboratory employees estimated that (b)(4)% of the test on the testing reports for 2020 and 2021 were actually conducted. Our investigator discussed this with you during the inspection closeout meeting. In your response submitted on January 5, 2022, you stated your corrective actions would include implementing HACCP plan CCP1 monitoring and verification activities. You submitted a revised HACCP plan, dated December 20, 2021, and monitoring records for five (5) consecutive days beginning on December 27, 2021, through December 31, 2021. We acknowledge that your revised HACCP plan includes a verification procedure to “(b)(4)” and provided an inter-laboratory comparison and verification report with your response. However, we have determined that your response is inadequate. Your laboratory comparison report only compares a single test from a single lot for (b)(4), which is not a representative sample. Furthermore, your report does not show that your test kits can detect aquaculture drugs at the reported level ((b)(4) ug/kg) as compared to the national standard method used in external laboratories.
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.
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. 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: Alyssa Piontkowski, 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 Alyssa Piontkowski via email at: Alyssa.Clendenin@fda.hhs.gov. Please include reference #629972 on any submissions and within the subject line of any emails to us.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied Nutrition