FDA WARNING_LETTER - Hacienda Mexican Foods, LLC - April 21, 2023

The FDA inspected a ready-to-eat (RTE) soft wheat flour tortilla manufacturing facility from April 3-21, 2023, identifying 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 RTE soft flour tortillas were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR 117.130(a)):** * Failure to identify and evaluate recontamination with environmental pathogens (e.g., Salmonella) as a hazard requiring sanitation controls, particularly at post-baking steps. The firm lacked adequate written sanitation procedures, corrective action procedures, and an effective environmental monitoring program (only testing for Enterobacteriaceae, not Salmonella). * Failure to identify and evaluate mycotoxins (e.g., vomitoxin in wheat flour) as a hazard requiring a supply-chain-applied preventive control. The firm lacked Certificates of Analysis (CoAs) from suppliers confirming vomitoxin testing. * Failure to appropriately identify and evaluate the survival of microorganisms due to low temperature (e.g., pathogenic E. coli, Salmonella) as a hazard requiring process controls during baking. The firm lacked written baking procedures, established