FDA WARNING_LETTER - Halperns' Steak & Seafood Company LLC - October 02, 2015

The FDA inspected Halperns’ Steak and Seafood Company, LLC's Dallas, Texas facility from September 22 to October 2, 2015, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their canned pasteurized crabmeat, histamine-forming fish, and caviar adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plans:** The caviar HACCP plan's critical limits at the Receiving CCP for pathogen control (including *Clostridium botulinum*) were insufficient, lacking specific temperature and transit time requirements. The revised histamine-forming fish HACCP plan's critical limit for cold storage was also deemed unsuitable due to difficulty in tracking cumulative time/temperature exposures. 2. **Inappropriate Corrective Actions:** Corrective action plans for caviar and histamine-forming fish at the Receiving CCP were inadequate, failing to address product received without proper cooling or to consider total time/temperature exposure for stored or processed fish. 3. **Inadequate Monitoring Frequency:** The histamine-forming fish HACCP plan's monitoring frequency for ice adequacy at the Storage CCP was insufficient, as observed inadequate icing after monitoring. Monitoring procedures for the Receiving CCP were also inadequate. 4. **Failure to Take Corrective Action:** The firm