FDA WARNING_LETTER - Gourmet Catering to Go, LLC - October 17, 2019

On February 3, 2020, the FDA issued a Warning Letter to Mr. Simmons, owner of an airline catering facility in Nashville, TN, following an inspection from September 27 – October 17, 2019. 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 the facility's Ready-To-Eat (RTE) products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Hazard Analysis (21 CFR § 117.130(a)):** Failure to conduct a hazard analysis for any products, specifically not identifying allergens (fish, dairy, tree nuts, eggs, ground nuts), biological hazards (E. coli O157:H7, Listeria monocytogenes, Salmonella) in raw ingredients (salmon, spinach, peppers), or environmental pathogens (Listeria monocytogenes, Salmonella) for RTE foods exposed to the environment. 2. **Preventive Controls (21 CFR § 117.135(a)(1)):** Failure to identify and implement preventive controls (process, allergen, sanitation, supply-chain, recall plan) to minimize or prevent identified hazards. 3. **Food Safety