La Villa Tortilleria, Inc. – FDA Warning Letter, Apr 22, 2011

On April 20 and 22, 2011, an FDA inspection of La Villa Tortilleria, Inc.'s corn tortilla manufacturing facility in Franklin, Tennessee, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render their corn tortilla products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions potentially leading to contamination.

Key violations include: 1. **Hygienic Practices (21 CFR 110.10(b)(3)):** Employees repeatedly handled raw dough and finished tortillas, picked up discarded tortillas from the floor, touched soiled clothing, adjusted equipment, and returned from other areas without washing hands. 2. **Sanitary Facilities and Controls (21 CFR 110.35(a)):** An electric leaf blower was used to clean the production room floor and tortilla conveyors, blowing debris into the air around processing equipment. 3. **Equipment Maintenance (21 CFR 110.40(a)):** A torn and stained plastic guide was used on the oven conveyor. Paper towels were used as gaskets in the tortilla forming machine, in direct contact with dough, after being dipped in a sanitizing solution with excessive chlorine (>200 ppm). 4. **Sanitizing Agents (21 CFR