FDA WARNING_LETTER - Grimm's Stone Crab Inc. - February 13, 2008

On February 11-13, 2008, the FDA inspected Grimm's Stone Crab Inc. and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). As a result, their raw fish (Mackerel, Kingfish, Bluefish) and Ready-to-Eat Stone Crab Claw products are considered adulterated.

Key violations include: 1. **Inadequate HACCP Plan for Raw Fish:** The HACCP plan for "Raw Fish: Mackerel, Kingfish, Bluefish" fails to list "Storage" as a critical control point for controlling histamine formation, despite the firm refrigerating fish after packing. 2. **Insufficient Monitoring Procedures:** The HACCP plan's monitoring procedure at the "Receiving" critical control point ("cook when temp type of fish") is inadequate for controlling histamine formation in raw fish received directly from harvest vessels. The FDA suggests monitoring harvest vessel records or performing histamine testing and decomposition checks. 3. **Lack of Sanitation Control Records:** The firm did not maintain required sanitation monitoring records for Ready-to-Eat Stone Crab Claws, specifically concerning water safety, toxic chemical management, employee health conditions, and pest control.

The FDA warns of potential further action, including product seizure or injunction, if violations are not promptly corrected. Grimm's