FDA WARNING_LETTER - Gourmail, Inc. dba Jyoti Natural Foods - May 01, 2014

On May 22, 2014, the FDA issued a Warning Letter to Gourmail, Inc., dba Jyoti Natural Foods, following an inspection from April 30 to May 1, 2014. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the firm's food products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Facility Construction and Maintenance (21 CFR 110.20(b)(4)):** * Water dripped from an exhaust vent in the ready-to-eat (RTE) airline meal production area onto a kettle lid with a gap, potentially contaminating in-process product. A tarp was placed as a temporary measure, but the roof repair timeline was not provided, and no permanent repair correspondence was received. * Stained, textured ceiling tiles, not easily cleanable, were observed directly above food preparation areas. The firm stated they would replace them, but no correspondence confirming replacement with easily cleanable tiles was received. 2. **Production Procedures and Contamination Prevention (21 CFR 110.80):** * A hose, used to add water directly to in-process product, was found with its nozzle resting on a visibly