FDA WARNING_LETTER - LSG SkyChefs DEN 235 - October 06, 2009

The FDA conducted an inspection of LSG SkyChefs' airline catering facility in Denver, Colorado, between September 17 and October 6, 2009, under the Public Health Service Act (PHS Act) to assess compliance with Interstate Conveyance Sanitation regulations (21 CFR Part 1250). The inspection revealed significant deviations, leading to a change in the facility's classification from "Approved" to "Provisional," with airline customers being notified. Key violations included failure to maintain clean premises free from vermin (21 CFR 1250.30(a)), with numerous live and dead roaches and insects observed. Deficiencies in food-handling operations (21 CFR 1250.32(a)) were noted, such as bare-hand contact, water dripping, and structural issues like gaps under doors and holes in walls. Utensils were improperly stored wet after bactericidal treatment (21 CFR 1250.33(c)), and plumbing was not maintained to prevent contamination (21 CFR 1250.30(d)), with hoses resting on floors. Garbage containers were not watertight or cleanable (21 CFR 1250.39), showing leaking fluids. Furthermore, environmental samples from the hot kitchen tested positive for Listeria monocytogenes. The firm's October 7, 2009, response detailing corrective actions for Listeria control and pest management was acknowledged, but these actions require FDA verification during a re-inspection within 30 days. Failure to correct deficiencies could result in a "Use Prohibited" classification. LSG SkyChefs must provide a written response within 15 working days outlining additional corrective steps and timelines.