FDA WARNING_LETTER - Fisherman's Catch Seafood Market - September 21, 2010

On September 15-21, 2010, the FDA inspected a seafood processing establishment at 919 E. Union Street, Morganton, NC. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The firm's tuna loins and mahi-mahi seafood products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under insanitary conditions.

Specific violations included: 1. Failure to conduct a proper hazard analysis and include all critical control points in the HACCP plan for crabmeat, specifically omitting storage as a critical control point for pathogen growth and toxin formation, violating 21 CFR 123.6(a) and (c)(2). 2. The HACCP plan for Mahi Mahi, Tuna, Amberjack, and Wahoo lacked monitoring procedures and frequencies at the receiving critical control point to control histamine formation, specifically not instructing employees to check for adequate ice on fish, violating 21 CFR 123.6(c)(4).

The FDA warned that failure to promptly correct these violations could result