FDA WARNING_LETTER - Donut Factory, LLC. - November 17, 2011

An FDA inspection of The Donut Factory, LLC, located at 6560 5th Ave S., Seattle, Washington, was conducted on November 10 and 15-17, 2011. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110), causing the firm's food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to exclude pests and protect against contamination (21 CFR 110.35(c))**: Extensive rodent excreta pellets (REPs) and rodent nesting material were found throughout the facility, including on platforms with ingredients, near processing areas, and in storage rooms. Live flies were observed in packaging and processing areas, with one landing on in-process raw donuts. Two live snails were found under a pallet of paper packaging materials. Samples collected confirmed rodent excreta pellets and hairs. 2. **Inadequate screening against pests (21 CFR 110.20(b)(7))**: The main west door and east loading door were observed open for extended periods, and three holes were found in the finished product storage room ceiling and walls. 3. **Improper use of sanitizing agents (21 CFR 110.35