FDA WARNING_LETTER - Euro USA Inc - July 25, 2023

On November 22, 2023, the FDA issued a Warning Letter to Euro USA, Inc. following an inspection from July 10-25, 2023, at their Cleveland, Ohio seafood processing facility. 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, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). These violations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plans:** Critical limits in HACCP plans for Combined Molluscan Shellfish (including shucked, raw scallops in cans), Pasteurized Crabmeat, and Scombroid Fish were inadequate to control *Clostridium botulinum* growth and toxin formation, pathogenic growth, and histamine formation. For instance, storage cooler temperatures frequently exceeded listed critical limits, and receiving critical limits for temperature control during transit were insufficient. 2. **Failure to Implement Monitoring Procedures:** The firm did not consistently follow monitoring and verification procedures listed in their HACCP plans, such as checking ice adequacy for Scombroid fish or taking internal fish temperatures. 3. **Inappropriate Corrective Actions:** Corrective actions