FDA WARNING_LETTER - Kitchen Garden Foods Ltd - October 27, 2023

On March 29, 2024, the FDA issued a Warning Letter to a facility in Stroud, Gloucestershire, GB, following an inspection from October 26-27, 2023. The inspection revealed serious deviations from the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm failed to respond to the FDA-483 Inspectional Observations.

Key violations include: 1. Failure to provide FDA with scheduled process information from a qualified process authority for new acidified food products (Onion Chutney, Fig Chutney, Plum Chutney) before packing, as required by 21 CFR 108.25(c)(2). The firm obtained a new FCE number but has not filed any scheduled processes. 2. Personnel involved in critical operations were not under the supervision of a person who satisfactorily completed an FDA-approved school (Better Process Control School), violating 21 CFR 108.25(f). 3. Product containers lacked proper identifying codes specifying the establishment, year, date, and packing period, as required by 21 CFR 114.80(b). The current coding system does not allow for positive identification of the product or its manufacture date.

These violations render the acidified food products adulterated under section 402