International Marine Products, Inc. – FDA Warning Letter, Aug 27, 2014

On October 29, 2014, the FDA issued a Warning Letter to International Marine Products, Inc. following an inspection of their Las Vegas, NV facility from August 25-27, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their ready-to-eat seafood products, including tuna, salmon, yellowtail, crabmeat, and anchovy fillets, adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to have written HACCP plans for receiving and storing pasteurized canned crabmeat (to control *Clostridium botulinum*) and refrigerated marinated anchovy fillets (to control histamine and pathogen growth). 2. **Inadequate Critical Limits:** The HACCP plans for vacuum-packaged yellowtail and raw salmon listed inadequate critical limits at the "Receiving" critical control point, failing to control pathogens, *Clostridium botulinum* toxin, and scombrotoxin formation. 3. **Inadequate Monitoring Procedures:** The HACCP plan for raw salmon had an inadequate monitoring procedure and frequency at the "Receiving" critical control point for pathogen control. 4. **Failure to Implement Monitoring Procedures:** The firm did not follow its own monitoring