FDA WARNING_LETTER - El Campestre Distributor - June 10, 2013

The FDA inspected El Campestre, Inc.'s seafood processing facility in Compton, CA, on multiple dates in May and June 2013, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's ready-to-eat seafood salads are deemed adulterated. Key deficiencies include the failure to conduct a comprehensive hazard analysis, resulting in a HACCP plan that omitted reasonably likely food safety hazards such as undeclared allergens, sulfites, and Clostridium botulinum growth. The HACCP plan also lacked critical control points for receiving, storage, and thawing to control pathogen growth. Furthermore, the firm failed to adequately monitor sanitation conditions, evidenced by visible product residue on cleaned equipment and observed employee cross-contamination practices. Sanitation control records for critical areas like water safety, cross-contamination prevention, and handwashing facilities were also not maintained for specified periods. The firm's July 17, 2013, response, including a new HACCP plan, was found inadequate. El Campestre, Inc. must promptly correct these violations and submit a detailed written response within 15 working days, including supporting documentation. Failure to comply may lead to product seizure, injunction, and reinspection fees. The FDA also noted the firm's HACCP plan incorrectly referenced USDA regulations instead of FDA's 21 CFR 123.7 and 123.8.