FDA WARNING_LETTER - Coombe Castle International Ltd. - October 31, 2023

The FDA issued a Warning Letter to Ingodmells Courtedinburgh Way, Melksham, Wiltshire, UK, following an inspection of their low-acid canned food (LACF) facility on October 30-31, 2023. The inspection revealed serious violations of the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113).

The primary violation cited was the failure to process LACF products in conformity with the scheduled process, as required by 21 CFR 108.35(c)(3)(i). Specifically, for 1 oz. CLOTTED CREAM, Lot #3303A was processed for a shorter duration than the filed schedule. For 6 oz. CLOTTED CREAM, the processing temperature used was lower than the filed schedule. These changes were made without consultation with a process authority or filing new process schedules with the FDA, violating 21 CFR 108.35(c)(2)(ii).

The company's responses from November 2023 to February 2024, including a Process Authority Report and updated manufacturing parameters, were deemed inadequate. The report did not demonstrate that products, as observed during the inspection, received a process rendering them free of microorganisms of public health significance. It was also unclear if