FDA WARNING_LETTER - Bridge Foods, Inc - February 13, 2015

On February 5-13, 2015, an FDA inspection of Bridge Foods, Inc.'s seafood processing facility revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The firm's ready-to-eat dried/smoked catfish was deemed adulterated under 21 USC 342(a)(4) due to insanitary conditions.

Key violations include: 1. Failure to conduct a proper hazard analysis and list critical control points (CCPs) in the HACCP plan for allergens and *Staphylococcus aureus* in dried smoked catfish (21 CFR 123.6(a) and (c)(2)). 2. Inappropriate corrective actions in the HACCP plan for dried smoked catfish at specific CCPs, failing to address the cause of deviations (21 CFR 123.7(b)). 3. Insufficient monitoring of sanitation conditions, specifically the absence of hand washing and sanitizing facilities in outdoor fish processing areas (21 CFR 123.11(b)). 4. Failure to maintain sanitation control records for various critical areas, including water safety, food contact surfaces, cross-contamination prevention, hand washing facilities, and pest control, on multiple occasions (21 CFR 123.11(c