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

Source: https://www.keypedia.com/records/warning_letter/hacienda-mexican-foods-llc/8cacffa0-6a03-4f7f-9500-167c13f126f8

> FDA WARNING_LETTER for Hacienda Mexican Foods, LLC on April 21, 2023. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Hacienda Mexican Foods, LLC
- Inspection Date: 2023-04-21
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: 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

## Related Officers

- [Program Director](https://www.keypedia.com/people/william-r-weissinger/4b648d9e-90cc-48e9-9bac-f782bed02d89)

Company: https://www.keypedia.com/companies/hacienda-mexican-foods-llc/fb6a87e0-32af-4714-9c2e-8874271b0810

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766