FDA WARNING_LETTER - An Xuyen Bakery, Inc. - September 17, 2012

The FDA inspected a bakery at 19043 International Blvd., Seatac, Washington, from September 11-17, 2012, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and misbranding issues under Section 403 of the Federal Food, Drug, and Cosmetic Act.

The inspection revealed adulterated food due to insanitary conditions, with laboratory analysis confirming house ants in white sugar bins and an open bag used for production. Significant violations included: 1. **Pest Control (21 CFR 110.35(c)):** Failure to exclude pests, with numerous live and dead ants and flies observed in ingredients, on shelving, and near equipment. 2. **Pest Protection (21 CFR 110.20(b)(7)):** Inadequate screening, with delivery doors, man doors, and office doors observed open, allowing pest entry. 3. **Pest Harborage (21 CFR 110.20(a)(1)):** Improper storage of equipment outside, creating attractants and harborage for pests, including birds. An unplugged, odorous refrigerator and standing water were also noted. 4. **Hand Washing (21 CFR 110.10(b)(3)):** Employees failed to wash hands after breaks or after soiling