FDA WARNING_LETTER - Gracie's Kitchens Inc. - November 25, 2024

Gracie"s Kitchens, Inc. received a Warning Letter from the FDA following an inspection of its New Haven, CT facility from November 4-25, 2024. 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). A primary concern was the repeated detection of *Listeria monocytogenes* (L. monocytogenes) in environmental samples collected from various areas, including food contact surfaces, during the November 2024 inspection. This pathogen was also found in April 2024, indicating persistent issues with sanitation controls. Significantly, whole genome sequencing linked one strain of L. monocytogenes found in the facility to clinical isolates known to cause human illness, leading to a recall of ready-to-eat (RTE) fruit and vegetable products. The FDA determined that the company failed to implement adequate preventive controls, specifically sanitation controls, to significantly minimize or prevent environmental pathogens like L. monocytogenes. This lapse led to the adulteration of RTE food products, as they were prepared or held under insanitary conditions, violating sections 402(a)(4) and 301(uu) of the Federal Food, Drug, and Cosmetic Act. While Gracie"s Kitchens, Inc. submitted responses outlining corrective actions, the FDA found them insufficient, indicating continuing concerns. The company is required to take comprehensive measures to identify and eradicate harborage sites for L. monocytogenes and ensure full compliance with preventive control regulations to prevent future contamination and ensure food safety.