FDA WARNING_LETTER - Ritter's Fish Market - July 25, 2012

The FDA inspected Ritter's Fish Market on July 24-25, 2012, and identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). Consequently, the firm's smoked fish (buffalo, catfish, sturgeon, carp) and pickled fish (pickled mullets) products are deemed adulterated. Key violations included the failure to implement the record-keeping system specified in their HACCP plans, lacking records for cooler temperature and pH monitoring. The firm's HACCP plans also had inadequate monitoring frequencies for critical control points, such as finished product cooler storage. Corrective action plans for temperature abuse were found inappropriate. Furthermore, the firm failed to monitor sanitation conditions and practices with sufficient frequency, leading to issues like a shovel on the floor, numerous flies, pooling water, a hose on the floor, and fish blood in the cooler. Finally, the firm did not maintain sanitation control records for various critical areas, including water safety, food contact surface cleanliness, and pest exclusion. The FDA requires a written response within 15 working days detailing corrective actions and providing supporting documentation. Failure to comply may result in product seizure, injunction, and re-inspection fees.