Greens Wholesale Distributors, Inc. – FDA Warning Letter, Jul 25, 2012

On September 13, 2012, the FDA issued a Warning Letter to Greens Wholesale Distributors, Inc. following an inspection on July 24-25, 2012. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110). Consequently, the firm's catfish products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Insufficient Sanitation Monitoring (21 CFR 123.11(b)):** The firm failed to adequately monitor eight sanitation areas. Issues observed included badly pitted and stained cutting boards, employees not washing hands after breaks, a restroom lacking soap/paper towels and a non-functional hand dryer, an unclean and poorly repaired hand wash sink, exposed storage of packaging boxes, unlabeled chemicals, numerous flies in the processing area, and cobwebs with dead flies. 2. **Improper Storage and Pest Control (21 CFR 110.20(a)(1)):** Facility grounds were littered with containers, tall grass, pallets, and trash, creating pest harborage. This was a repeat violation. 3. **Unsanitary Facility Maintenance (21 CFR 110.3