FDA WARNING_LETTER - mongiello italian cheese specialties, inc. - August 13, 2013

The FDA conducted an inspection of Mongiello Italian Cheese Specialties, Inc. (Formaggio) in July and August 2013, following USDA FSIS notifications of *Listeria monocytogenes* in finished products and environmental samples. The inspection revealed significant insanitary conditions violating FDA's Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 110. Environmental swabs collected by FDA also confirmed *L. monocytogenes* presence, and PFGE analysis showed these strains were indistinguishable from USDA samples, indicating widespread contamination and established niche areas. This renders the firm's cheese adulterated under 21 U.S.C. § 342(a)(4).

Key violations included: failure to prevent drip/condensate contamination (21 CFR § 110.20(b)(4)); inadequate protection against contamination from foreign substances like sleeve arms contacting food (21 CFR § 110.10(b)(9)); employees not sanitizing hands thoroughly (21 CFR § 110.10(b)(3)); inadequate sanitary plumbing (21 CFR §110.37(b)(3)); and insufficient pest protection (21 CFR § 110.20(b)(7)). The letter highlights the serious public health concern of *L. monocytogenes*. The firm must respond within 15 working days with specific corrective actions and prevention plans. Failure to comply could result in product seizure, injunction, and reinspection fees.