FDA WARNING_LETTER - Gate Gourmet Inc. - December 01, 2017

This FDA Warning Letter, dated December 29, 2017, informs Gate Gourmet, Inc. of a reclassification of their Erlanger, Kentucky airline catering facility from "Approved" to "Provisional" due to serious violations observed during an inspection on November 29 and December 1, 2017. The inspection, conducted under the FDCA and PHS Act, found the facility in violation of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 117) and Interstate Conveyance Sanitation regulations (21 CFR Part 1250).

The identified violations caused food products to be adulterated under Section 402(a)(4) of the FDCA. Significant CGMP violations include: 1. **Failure to exclude pests (21 CFR Part 117.35(c)):** Evidence of live and dead cockroaches, unsealed pipe penetrations with fecal markings, and non-operational equipment serving as harborage were observed. Pest control reports from June-November 2017 also indicated high cockroach activity. 2. **Failure to maintain equipment and minimize contamination (21 CFR Part 117.80(c)(1) & (2)):** Heavy build-up of grease, food deposits, and filth on non-food contact surfaces of cooking equipment, soiled floors, standing water, and dirty dust pans near food preparation areas were noted.