FDA WARNING_LETTER - Meek's Seafood, Inc. - June 10, 2008

On June 4-6 and 10, 2008, an FDA inspection of Meek's Seafood, Inc. in Larose, Louisiana, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). These violations render the firm's ready-to-eat crabmeat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement monitoring procedures:** The firm did not monitor or record cook water temperatures, cool-down temperatures, internal temperatures of backed crabs, or time products were exposed to unrefrigerated conditions at various critical control points (CCPs) in their "Blue Crab/Ready-to-eat Fresh Crabmeat" HACCP plan. 2. **Inadequate HACCP plan:** The HACCP plan lacked a CCP for refrigerated storage of unpicked backed crabs and crab claws to control pathogen growth. 3. **Inappropriate corrective actions:** The listed corrective actions in the HACCP plan (e.g., "Segregate hold for evaluation," "Move to other cooler") were deemed insufficient to ensure product safety or address the cause of deviations. 4. **Failure to take corrective action:** The firm did not take corrective action when a batch