FDA WARNING_LETTER - The Crab Lady's Market - July 13, 2012

On August 3, 2012, the FDA issued a Warning Letter to The Crab Lady's Market, owned by Ms. Tina M. Gray, following an inspection from July 10-13, 2012, at their seafood processing facility in Little Deer Isle, Maine. 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 ready-to-eat crabmeat was adulterated because it was prepared, packed, or held under insanitary conditions. Specific violations included:

1. **Failure to Implement Record Keeping System (21 CFR 123.6(b) and (c)(7)):** The firm did not record monitoring observations at critical control points (CCPs) as required by their HACCP plan. This included a lack of cooking time data after July 12, 2011, and no temperature data for refrigerated storage or picking after June 29, 2011. 2. **Inadequate HACCP Plan Monitoring Procedures (21 CFR 123.6(c)(4)):** The HACCP plan's monitoring procedures for the Refrigerated Storage CCP were insufficient to ensure continuous compliance with the critical limit of 40°