FDA WARNING_LETTER - bek catering llc - September 29, 2011

The FDA inspected BEK Catering LLC dba Floppers Food's seafood processing facility on September 28-29, 2011, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). Consequently, the firm's seafood products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the firm's failure to conduct a hazard analysis and implement written HACCP plans for products like Mama's Gumbo, Shrimp Locksley, and Crawfish Locksley, specifically to control food safety hazards such as allergens and pathogen growth from time/temperature abuse, as required by 21 CFR 123.6(a) and (b). Additionally, the firm failed to maintain adequate sanitation control records, as mandated by 21 CFR 123.11(c), for critical areas including food contact surfaces, cross-contamination prevention, handwashing facilities, food protection, toxic chemical management, employee health, and pest control. The FDA requires a written response within fifteen working days, detailing specific corrective actions taken, supported by documentation such as HACCP and verification records. Failure to promptly correct these violations may result in further regulatory action, including product seizure or an injunction against the firm's operations. The firm is responsible for ensuring full compliance with all applicable regulations.