Gioia Cheese Company Inc. – FDA Warning Letter, Aug 29, 2012

The FDA inspected Gioia Cheese Co., Inc. from August 22-29, 2012, and found significant violations, including the presence of Listeria monocytogenes (L. monocytogenes) in environmental samples. This finding, coupled with observed Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), renders the firm's ready-to-eat cheese products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. ? 342(a)(4)] due to insanitary conditions. This marks the third instance since 2010 that L. monocytogenes has been detected at the facility, with PFGE results suggesting a persistent strain and inadequate sanitation efforts. Specific CGMP violations included failure to protect work-in-progress from contamination (21 CFR 110.80(b)(5)), improper handling and maintenance of equipment and containers (21 CFR 110.80(b)(7)), and inadequate plumbing installation and maintenance to prevent water supply contamination (21 CFR 110.37(b)(3)). The presence of Listeria seeligeri in cheese products further indicated conditions allowing Listeria contamination. The FDA acknowledged the firm's response regarding L. monocytogenes testing but noted it did not address CGMP deviations. The firm must implement comprehensive corrective actions, including effective environmental monitoring, to control pathogens and prevent recurrence. Failure to comply may lead to enforcement actions like seizure or injunction, and reinspection fees. A written response detailing corrections and a timetable is required within fifteen business days.