Captain Jackie's Seafood, Inc. – FDA Warning Letter, Apr 2, 2008

On March 26-28 and April 2, 2008, an FDA inspection of Captain Jackie's Seafood, Inc. in Theodore, Alabama, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110).

The primary violation identified was the firm's failure to implement its record-keeping system for the receiving critical control point to control histamine formation in histamine-forming fish (e.g., Spanish Mackerel, Bluefish, King Mackerel). Specifically, the firm failed to record monitoring observations during the receipt of histamine-forming fish on 60 occasions between June and December 2007, as required by 21 CFR 123.6(b) and (c)(7). This renders the firm's histamine-forming fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 USC 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA requires a written response within fifteen working days outlining specific corrective actions, including supporting documentation like HACCP and monitoring records. Failure to promptly correct these violations may result in further regulatory action, including product seizure and/or injunction against the firm's operation. The letter emphasizes