FDA WARNING_LETTER - J & B Seafood Inc. - June 23, 2017

On September 19, 2017, the FDA issued an amended Warning Letter to J & B Seafood, Inc. following an inspection from June 19-23, 2017, at their Coden, Alabama facility. 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 (CGMP) regulation (21 CFR Part 110).

The firm's fresh picked crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Seafood HACCP - Corrective Actions (21 CFR 123.7(a)):** The firm failed to take appropriate corrective actions when the cooking process for crabmeat deviated from the critical limit for pathogen survival. The Daily Cooking Log showed numerous instances where the stated cooking critical limit was not met, and no corrective actions (e.g., segregation, evaluation, re-cooking, cause correction) were documented. 2. **Sanitation Monitoring (21 CFR 123.11(b) and 21 CFR Part 110):** The firm did not monitor sanitation with sufficient frequency, evidenced by: * Live flies landing on cooked crabs, crab parts