FDA WARNING_LETTER - Walter's Seafood, Inc. - April 17, 2008

On August 8, 2008, the FDA issued a Warning Letter to Walter's Seafood, Inc. following an inspection from April 15-17, 2008. 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 FDA determined that the firm's Scombroid-toxin forming fish species (Mahi Mahi, Tuna, Wahoo, Mackerel, etc.), Canned Pasteurized Crab Meat, and Ready to Eat Stone Crab Claws were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific violations included: 1. Failure to implement record-keeping systems for monitoring observations at the "Receiving" critical control point for "Cooked Crab Products (Pasteurized Crab Meat)," violating 21 CFR 123.6(b). 2. Inadequate monitoring procedures in the HACCP plan for Scombroid-toxin forming species, where "2 times daily to check if recorder is working" was insufficient to ensure compliance with critical limits, violating 21 CFR 123.6(c)(4). 3. Failure to implement the specified monitoring