FDA WARNING_LETTER - Haitai, Inc. - May 20, 2015

On June 29, 2015, the FDA issued a Warning Letter to Haitai Inc. following an inspection on May 20, 2015, at their seafood importer establishment in Montebello, CA. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, which pertains to imported fish and fishery products.

The primary violation cited was the firm's failure to have or implement written verification procedures, product specifications, and an affirmative step to ensure imported fish comply with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2). This deficiency was specifically noted for Dried Alaska Pollack, Frozen Salted Mackerel, and Frozen Imitation Crabmeat.

As a result of these violations, the aforementioned products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), meaning they were prepared, packed, or held under insanitary conditions potentially rendering them injurious to health.

Haitai Inc. was instructed to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records. Failure to promptly correct these violations could lead to