Quinault Indian Nation – FDA Warning Letter, Jan 15, 2010

On January 14-15, 2010, the FDA inspected a food commodity warehouse at 166 First Avenue, Taholah, Washington, finding serious deviations from 21 CFR Part 110 (CGMP for foods), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Significant violations included: 1. **Pest Control (21 CFR 110.35(c)):** Failure to exclude rodents and protect against contamination. A live rodent was observed, and extensive rodent excreta pellets (REPs) and nesting material were found throughout the warehouse, including under pallets, near a forklift, and in corners. Fluorescent urine stains were also noted. 2. **Food Storage (21 CFR 110.93):** Failure to store finished food to protect against contamination. Observations included water leaking from the ceiling near packaged food, pooled water on the floor near food, and cardboard cases of food stored directly on the floor. 3. **Building Maintenance (21 CFR 110.35(a)):** Failure to maintain the building in a sanitary condition and in sufficient repair. Issues included falling insulation, gaps in ceilings and walls, and detached/stained false ceiling tiles throughout the facility. 4. **Pest Harborage (21 CFR 1