FDA WARNING_LETTER - Flying Food Group, LLC - March 06, 2019

The FDA inspected a ready-to-eat (RTE) food manufacturing facility from February 25 to March 6, 2019, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Environmental samples revealed *Listeria monocytogenes* (L. mono), including the same strain found in 2017 and 2018 inspections, indicating a resident pathogen. Five positive swabs were from food contact surfaces, and six were from adjacent areas. This led to the determination that RTE food manufactured is adulterated under 21 U.S.C. § 342(a)(4).

Violations include: 1. **Hazard Analysis (21 CFR § 117.130(a)(1))**: Failure to identify environmental pathogens as a hazard requiring a preventive control, despite RTE foods being exposed to the environment and repeated L. mono findings. Sanitation controls (SSOPs) and environmental monitoring were incorrectly considered when determining the need for preventive controls. 2. **Preventive Controls (21 CFR § 117.135(a)(1))**: Inadequate sanitation controls to significantly minimize or prevent L. mono, as evidenced by the resident strain. 3. **Current Good Manufacturing Practice (21 CFR § 117.35