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

Source: https://www.keypedia.com/records/warning_letter/saritas-tortilla-factory-inc/ec145386-9a1c-4b1e-ac1d-d9bf7abbaa20

> FDA WARNING_LETTER for Sarita's Tortilla Factory, Inc on July 12, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sarita's Tortilla Factory, Inc
- Inspection Date: 2021-07-12
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations West Division 3
- Summary: 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

## Related Documents

- [483 - 2021-07-12](https://www.keypedia.com/records/483/saritas-tortilla-factory-inc/0ed290b9-b024-46ea-b402-a5685cee261b)

## Related Officers

- [Director](https://www.keypedia.com/people/lori-woznicki/41fabd4c-c917-439b-a6cb-d21ee3552cab)
- [Program Director](https://www.keypedia.com/people/edmundo-garcia/d47fc6d7-1ed9-4a65-bcaf-b3860041ca55)

Company: https://www.keypedia.com/companies/saritas-tortilla-factory-inc/d479ad45-ffa3-44f2-8c04-b21e7f24e394

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-west-division-3/e7f2e5ac-b72b-49d5-b816-8e5520334bee