On May 23, 2017, the United States Food & Drug Administration sent a warning letter to A.I. Foods Corporation of Los Angeles regarding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
As of July 2017, only seven companies in the Los Angeles area have received warning letters from the USFDA. AI Foods was one of those seven.
The letter, sent via UPS, was addressed to Clarissa A. Takakawa, the CEO of AI Foods, a known Filipino American food company in the United States, although her surname was misspelled as Takawaka.
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, A.I. Foods has to 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 the USFDA inspection identified serious violations for 21 CFR Part 123, AI Foods’ fish sauce and frozen plain deboned milkfish are considered 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.
Readers may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links on the FDA’s home page at www.fda.gov.
A.I. Foods’ significant violations were as follows:
• Did not comply with 21 CFR 123.12(a)(2) in that the company does not have or has not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish and fishery products it imported are processed in compliance with the Seafood HACCP regulation. Specifically, it failed to provide adequate product specifications and an affirmative step for the following products:
o Fish Sauce manufactured by (b)(4)
o Frozen Plain Deboned Milkfish (bangus) manufactured by (b)(4)
* (b)(4) not publicly named.
The USFDA may take further action if AI Foods does not promptly correct these violations. For instance, the USFDA may take further action to refuse admission of AI’s 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 AI’s product(s) and/or enjoin the firm from further violating the Act.