FDA 483 - Adesa International LLC. - July 24, 2025

A Seafood/Food Manufacturer in San Bernardino, CA, was subject to an FDA inspection between July 17 and July 24, 2025, which identified four significant deficiencies documented on a Form FDA 483. The most critical observations pertained to the firm's Hazard Analysis and Critical Control Point (HACCP) plan for Shrimp Cocktail and Shrimp Broth in Reduced Oxygen Packaging. The plan was found to be inadequate, lacking critical control points to address environmental chemical and aquaculture drug hazards at the receiving stage, and failing to establish effective temperature controls to prevent the growth of Clostridium botulinum during receiving, cooling, and storage/shipping of these products. Additionally, the firm did not execute corrective actions despite documented temperature deviations in storage areas. Further issues included a failure to consistently implement HACCP monitoring and recordkeeping procedures, with cooking parameters not adequately tracked and broth temperatures recorded below critical limits. Sanitation practices were also cited; an employee dropped and reused a food contact hose without sanitization, and observations revealed damaged processing equipment and facility floors. Lastly, the individual responsible for managing the Seafood HACCP plan was found to lack the necessary training or experience in fish and fishery product HACCP principles. The firm must promptly address these observations to ensure compliance with federal food safety regulations.