Mexicantown Bakery, Inc – FDA Warning Letter, Nov 4, 2014

The FDA inspected Mexicantown Bakery, Inc. from October 24 to November 4, 2014, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering food adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, Orejas and Concha products were found to be misbranded under Section 403 of the Act.

Key violations included: 1. **Hygienic Practices (21 CFR 110.10(b))**: Employees handled unsanitized waste and then food without washing hands, and touched nut-containing products before handling nut-free products, risking allergen cross-contamination. The firm's response lacked documentation of employee instruction or monitoring. 2. **Pest Control (21 CFR 110.35(c))**: Rodent excreta, gnawed bags, a dead rodent, and live insects were observed. Gaps in doors and walls allowed pest entry. The firm's response to increase extermination frequency did not address preventing entry or provide effectiveness documentation. 3. **Handwashing Facilities (21 CFR 110.37(e)(2))**: Lack of paper towels, trash receptacles, and handwashing signs. A bin was placed in a hand