FDA WARNING_LETTER - Classic Catering & Commissary Corp. - December 20, 2007

An FDA inspection of Classic Catering & Commissary Corp.'s seafood processing facility on December 18 and 20, 2007, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's refrigerated ready-to-eat tuna salad sandwiches were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key deficiencies included the HACCP plan's failure to identify scombrotoxin formation as a food safety hazard (21 CFR 123.6(a), (c)(1)) and inadequate monitoring procedures for the "Refrigerate" critical control point, specifically intermittent temperature checks insufficient to control scombrotoxin and pathogen growth (21 CFR 123.6(c)(4)). The firm's corrective action plan for this CCP was also deemed inappropriate (21 CFR 123.7(b)). Furthermore, the company failed to maintain required sanitation monitoring records for various critical areas, including water safety, food contact surfaces, cross-contamination prevention, hand washing, product protection, toxic chemicals, employee health, and pest exclusion, for extended periods (21 CFR 123.11(c)). Additionally, HACCP monitoring records for refrigerated products were retained for only three months, falling short of the required one-year retention period (21 CFR 123.9(b)(1)).

The FDA requires a written response within fifteen working days detailing specific corrective actions, supported by documentation. Failure to promptly correct these violations may lead to further regulatory action, including product seizure or injunction against the firm's operations. The company is responsible for ensuring full compliance with all applicable regulations.