Natural Choice Distribution Company – FDA Warning Letter, Feb 22, 2011

On February 8-22, 2011, the FDA inspected Natural Choice Distribution Company's seafood processing facility, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Significant violations include: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for albacore tuna with ginger wasabi sandwich to control pathogens and Histamine toxin, violating 21 CFR 123.6(a) and (b). 2. **Inadequate Sanitation Monitoring:** The firm failed to sufficiently monitor sanitation conditions and practices, violating 21 CFR 123.11(b). Evidence included mold-like material on walls, dirty bins used for food, employees handling garbage and touching faces without hand washing, lack of hand sanitizer, failure to sanitize food contact equipment (bypassing sanitizer dispenser), and presence of flies with a hole in the assembly room door.

Additionally, product labels for Fare & Square Albacore Tuna with Ginger Wasabi, Superfresh Foods! Vegetarian Smoked Turkey, and Real Wraps Burrito Grande were found to