FDA WARNING_LETTER - Pierino Frozen Foods, Inc. - November 29, 2012

On January 10, 2013, the FDA issued a Warning Letter to Pierino Frozen Foods, Inc. following an inspection from November 7-29, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their Gourmet Crab Ravioli and Lobster Ravioli adulterated.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for Gourmet Crab Ravioli and Lobster Ravioli to control *Clostridium botulinum* formation during the thawing of vacuum-packed crab and lobster meats, and metal inclusion during filling preparation. This was a repeat violation from a February 2010 inspection. The firm's December 13, 2012, response was deemed inadequate as it did not address these hazards or provide a HACCP plan. 2. **Insufficient Monitoring Procedures:** The HACCP plan lacked sufficient monitoring frequency for critical control points. Specifically, refrigerator temperatures during thawing were not monitored frequently enough, including weekends, to control *Clostridium botulinum*. FDA recommends continuous monitoring. 3. **Inadequate Sanitation Records:** The firm failed to maintain sanitation monitoring records for hand washing, hand sanitizing, toilet facilities, proper labeling/storage/use of toxic compounds, and control of employee health conditions.