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

Source: https://www.keypedia.com/records/warning_letter/mena-food-group-llc/f651461e-79fa-4c98-9888-013c74f917f3

> FDA WARNING_LETTER for Mena Food Group, LLC. on November 20, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mena Food Group, LLC.
- Inspection Date: 2023-11-20
- Product Type: Food
- Office Name: Office of Regulatory Affairs
- Summary: 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

## Related Officers

- [Program Director](https://www.keypedia.com/people/ramon-a-hernandez/12807db4-f78b-4579-b66c-bae9096ec2d4)

Company: https://www.keypedia.com/companies/mena-food-group-llc/a8de5d7d-63cd-4f74-8d44-176a0e432221

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64