Eckerd Seafood, Inc. – FDA Warning Letter, Jun 17, 2010

On November 1, 2010, the FDA issued a Warning Letter to Eckerd Seafood, Inc. following an inspection from June 15-17, 2010. 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 found that Eckerd Seafood's fresh pasteurized crabmeat, fresh crabmeat, vacuum-packed fresh or smoked fish, and scombrotoxin species fish were adulterated because they were prepared, packed, or held under insanitary conditions.

Key violations included: * **Inadequate HACCP Plan Monitoring Procedures:** The HACCP plan for "fresh pasteurized crabmeat, fresh crabmeat, vacuum packed fresh or smoked fish" had an inadequate monitoring frequency for the storage critical control point. The plan stated a critical limit for cooler temperature not to exceed (b)(4) for more than (b)(4) hours, with visual checks (b)(4) times per day. This frequency (3 data points per 24 hours) was insufficient to meet the critical limit based on (b)(4) hour intervals. The FDA recommended 24/7 temperature monitoring and recording. * **Inadequate HACCP Plan Critical Limits:** The HACCP plan's critical limit for storage ((b)(4