Hacienda Mexican Foods, LLC Warning Letter Details

Summary

Hacienda Mexican Foods, LLC received a warning for serious violations at its ready-to-eat soft wheat flour tortilla manufacturing facility in Detroit, Michigan, including failure to comply with Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117. FDA inspectors found that the tortillas were prepared, packed, or held under insanitary conditions, creating potential contamination with filth or substances that could render the products injurious to health. Additionally, the company's "SOY FREE" label claims were false or misleading, making the products misbranded. The violations were identified during an FDA inspection conducted from April 3-21, 2023, and despite the company's corrective action responses submitted in May and June 2023, FDA determined the issues warranted formal warning letter enforcement.