FDA WARNING_LETTER - Mena Food Group, LLC. - November 20, 2023

The FDA inspected a facility in Fort Lauderdale, FL, from October 30 to November 20, 2023, manufacturing ready-to-eat (RTE) bakery products. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering products adulterated under 21 U.S.C. § 342(a)(4). Additionally, products were found to be misbranded under 21 U.S.C. § 343 due to non-compliance with 21 CFR Part 101 regarding food labeling.

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** * Failure to identify and evaluate recontamination with environmental pathogens (e.g., Salmonella, Listeria monocytogenes) as a known or reasonably foreseeable hazard for RTE products, requiring environmental monitoring (21 CFR 117.130(a)(1), 21 CFR 117.135(c)(3), 21 CFR 117.165(a)(3)). * Failure to identify and evaluate mycotoxins (e.g., deoxynivalenol) in high protein wheat flour as a known or reasonably foreseeable hazard, and lack of a risk