FDA WARNING_LETTER - Quality Beef Company, Inc. - November 15, 2013

On December 16, 2013, the FDA issued a Warning Letter to Quality Beef Company, Inc. following an inspection from November 8, 12, and 15, 2013. 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, refrigerated seafood salad and imported, ready-to-eat, refrigerated salted smoked herring fillets adulterated.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for seafood salad and smoked herring fillets listed an inadequate critical limit at the receiving critical control point to control pathogen growth. Monitoring of incoming shipments was also insufficient, with only a single unit's temperature checked. 2. **Insufficient Monitoring Procedures:** The HACCP plan's monitoring frequency for "Cooler Storage" was inadequate for pathogen control. The firm also failed to implement the stated monitoring procedure of visually observing the calibrated cooler wall thermometer. 3. **Lack of Import Verification Procedures:** The firm had no written import verification procedures or affirmative steps for imported ready-to-eat, refrigerated salted smoked herring fillets from Canada.

The firm's November 20, 2013, response to the FDA 483 was deemed inadequate as it lacked revised HACCP plans, evidence of continuous monitoring, or implementation of import controls