FDA WARNING_LETTER - Tao Ling Seafood Inc - September 24, 2015

On November 17, 2015, the FDA issued a Warning Letter to Tao Ling Seafood Inc. following an inspection on September 24, 2015, at their Pico Rivera, CA, facility. 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 governs imported fish and fishery products.

The primary violation identified was the absence or non-implementation of written verification procedures, product specifications, and an affirmative step to ensure imported fishery products comply with the Seafood HACCP regulation. This deficiency was specifically noted for frozen shrimp manufactured by (b)(4). Consequently, the firm's shrimp is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

Tao Ling Seafood Inc. must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, and affirmative step performance. Failure to correct these violations may result in refusal of admission for imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/or injunctions. The firm is responsible