FDA WARNING_LETTER - BEK Catering, LLC dba Floppers Foods - March 05, 2014

The FDA inspected BEK, LLC dba Floppers Food's seafood processing facility in early 2014, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110). These deficiencies render the firm's seafood products adulterated under 21 USC 342(a)(4).

Key violations include HACCP plans lacking adequate critical limits for cooking Seafood Gumbo and Shrimp Locksley to control pathogens, and failing to list essential critical control points (e.g., cooling, storage, pouring) for pathogenic bacteria growth. The plans also omitted reasonably likely food safety hazards, such as allergens (wheat), at the labeling critical control point. Furthermore, the firm failed to implement monitoring procedures listed in its HACCP plans and did not maintain required comprehensive sanitation control records for various critical areas, including food contact surfaces and cross-contamination prevention. An employee was also observed not wearing suitable outer garments, posing a contamination risk.

FDA deemed the firm's responses to the inspectional observations largely inadequate. The company is required to promptly correct all cited violations, investigate their root causes, and submit a written response within 15 working days detailing specific corrective actions, supporting documentation, and a timetable for full compliance to avoid potential regulatory actions like seizure or injunction.