David H. Hua, President
Dear Mr. Hua:
We inspected your seafood importer establishment, located at 950 South 3rd
Street, San Jose, California, on December 15 - 20, 2010.
We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your fish sauce and frozen salted fish are adulterated under Section 402(a)(4)of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
Your significant violations are as follows:
- You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm imports fish sauce from Thailand and you do not have product specifications to address the hazard of histamines.
- You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the importation of your Fish Sauce imported from (b)(4); and your Frozen Salted Fish imported from (b)(4). Your affirmative step for each of these products is maintaining a copy of the foreign processor’s HACCP plan, in compliance with 21 CFR 123.12 (a)(2)(ii) (D). However in order to fully comply with 21 CFR 123.12 (a)(2)(ii) (D) you must also maintain a copy, in English, of a written guarantee from the foreign processor indicating that the imported fish and fishery product was processed in accordance with the FDA seafood HACCP regulation; and your
Please be advised that products that are frozen and packaged under oxygen impermeable films need to display thawing instructions, indicating that the products should be thawed under refrigeration and used immediately to reduce the likelihood for Clostridium botulinum toxin formation during thawing.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance
Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov
We may take further action if you do not promptly correct this violation. 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," seize your product(s) and/or enjoin your firm from further violating the Act.
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 violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your written reply to the Food and Drug Administration, Attention: Sergio Chavez, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.
Barbara J. Cassens