FDA WARNING_LETTER - Chang Jiang Seafood Ca Inc - February 02, 2015

On March 9, 2015, the FDA issued a Warning Letter to Chang Jiang Seafood CA, Inc. following an inspection on January 22 and February 2, 2015. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The FDA found that the firm's Frozen Fish Balls, IQF Farm Raised PND Frozen Shrimp, and Wild Caught Frozen Baby Octopus were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations included: 1. Failure to have product specifications designed to ensure imported fish and fishery products are not injurious to health or processed under insanitary conditions (21 CFR 123.12(a)(2)(i)) for the aforementioned products. 2. Failure to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with the seafood HACCP regulation (21 CFR 123.12(a)(2)(ii)) for the same products.

The FDA warned that failure to correct these violations could lead to refusal of admission of imported products, detention without physical examination, seizure, and/or injunction. The firm