FDA WARNING_LETTER - Sarita's Tortilla Factory, Inc - July 12, 2021

The FDA inspected a tortilla manufacturing facility at 2505 El Indio Hwy., Eagle Pass, TX, on July 7-12, 2021, as a follow-up to a July 2019 inspection. Both inspections revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The facility's ready-to-eat (RTE) tortilla products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Failure to implement a food safety plan** overseen by a preventive controls qualified individual (PCQI), lacking a written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures (21 CFR § 117.126(a)(1)). 2. **Failure to conduct a hazard analysis** for allergens (wheat, milk), environmental pathogens (Salmonella) for RTE products, and mycotoxins (deoxynivalenol, aflatoxin) in flour ingredients (21 CFR § 117.130(a)). 3. **Failure to identify and implement preventive controls**, specifically for allergen cross-contact (e.g., shared uncleaned utensils for allergenic