FDA WARNING_LETTER - Cajun Crab, LLC - November 06, 2010

On November 3-6, 2010, FDA investigators inspected Cajun Crab, LLC's seafood processing facility in Chauvin, Louisiana, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render their ready-to-eat crabmeat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. Failure to implement monitoring procedures and frequency listed in the HACCP plan for fresh crabmeat's cooling critical control point (CCP) to control pathogen growth and toxin formation. Records showed internal crab temperatures were not monitored as frequently as required, failing to ensure temperatures reached and maintained specified limits within the required timeframe. 2. The HACCP plan for fresh crabmeat lists an inadequate critical limit at the cooling CCP to control pathogen growth and toxin formation. The FDA recommends limiting total time above 50°F to 4 hours, with no more than 2 hours above 70°F, when cooked crabmeat is handled significantly and further processed after cooling. 3. The corrective action plan for fresh crabmeat at multiple CCPs (cooling, picking, packing, and storage) to control pathogen growth and