La Mexicana, Inc. – FDA Warning Letter, Oct 7, 2009

The FDA conducted an inspection of a food processing facility at 10022 16th Avenue Southwest, Seattle, Washington, on October 1, 2, 5, and 7, 2009, to assess compliance with 21 CFR Part 110 (CGMP for foods). The inspection revealed serious deviations, rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Failure to exclude ill employees (21 CFR 110.10(a)):** An employee with an open sore on their forearm directly handled dough, placing the arm into bulk dough. 2. **Failure to conform to hygienic practices (21 CFR 110.10(b)(3), (5), (9)):** Employees failed to wash/sanitize hands or change soiled gloves after leaving workstations, handling raw ingredients, or taking breaks. Gloves were improperly stored and reused. 3. **Failure to minimize contamination potential (21 CFR 110.80(b)(2), (5)):** Tortillas were manufactured under flaking vent ducts. Scrap dough was contaminated by contact with soiled non-food contact surfaces. Fans blowing onto finished products were covered in dust/flour. Oil and dough softener were stored near a soiled, cracking wall and hand