FDA issued warning letter CMS #663221 dated April 4, 2024, to Hacienda Mexican Foods LLC after inspecting its ready-to-eat soft wheat flour tortilla facility at 6016 E. Vernor Hwy., Detroit, MI, from April 3–21, 2023.
Investigators cited failures to identify hazards requiring preventive controls — including environmental pathogen recontamination (Salmonella) after bake, mycotoxins/vomitoxin in wheat flour, and validated baking process controls — plus CGMP findings on sanitation, facility repair, and pests (live cockroaches observed). FDA also said 313 Urban Tortillas “Soy Free” claims were false or misleading because products used soy-based shortening.
The letter concludes RTE soft flour tortillas were adulterated under section 402(a)(4) and that PC-rule failures are prohibited under section 301(uu), with additional misbranding findings under 403(a)(1) and 403(q).
Read the full FDA warning letter for observation-by-observation detail and the firm’s response status as of the letter date.
Hacienda Mexican Foods