Ham Produce & Seafood, Inc. – FDA Warning Letter, May 20, 2015

On July 13, 2015, the FDA issued a Warning Letter to Ham Produce and Seafood, Inc. following an inspection from May 13-20, 2015, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's fresh, refrigerated seafood, including tuna, was deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Failure to take appropriate corrective action (21 CFR 123.7(a)):** The firm did not take corrective action when cold storage temperatures for tuna (intended for raw consumption) exceeded the critical limit of 40°F on multiple occasions in April and May 2015. The firm's understanding of a "continuous cumulative time of 4 hours" was deemed inadequate, as cumulative time includes all periods above 40°F. 2. **Failure to implement recordkeeping system (21 CFR 123.6(b)):** The firm did not maintain required monitoring records for the Cold Storage critical control point. 3. **Insufficient monitoring of sanitation conditions (21 CFR 123.11(b)):** * **Safety of water (21 CFR 1