FDA WARNING_LETTER - a.m. wholesale fish co. inc. - February 05, 2014

On January 30, 2014, through February 5, 2014, the FDA inspected A.M. Wholesale Fish Co., Inc. dba Syosset Seafood Co. in Dallas, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their canned pasteurized crabmeat, smoked salmon, and caviar adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for canned pasteurized crabmeat had inadequate critical limits at the Receiving critical control point to control pathogen growth and toxin formation, specifically *Clostridium botulinum*. The critical limits for temperature and transit time were insufficient, and the firm accepted shipments without adequate temperature monitoring data. 2. **Failure to Take Corrective Action:** The firm did not take appropriate corrective actions when critical limits were exceeded for cold smoked salmon. Temperature charts showed cooler temperatures exceeding 40°F for approximately 3 hours on multiple dates, with no documented corrective actions. 3. **Failure to Implement Monitoring Procedures:** The firm did not consistently follow monitoring procedures listed in their HACCP plans. This included not monitoring temperature adequately for incoming pasteurized canned crabmeat shipments and not conducting visual checks of continuous temperature monitoring devices on weekends