FDA WARNING_LETTER - Losurdo Foods, Inc. - March 18, 2014

The FDA inspected Losurdo Foods, Inc. in Amsterdam, New York, from February 10-21, 2014, and March 18, 2014, finding serious violations. Environmental samples revealed Listeria monocytogenes in 18 of 72 swabs from the Cheese and Bun Rooms, including direct food contact surfaces, indicating inadequate sanitation and rendering food products adulterated under 21 U.S.C. § 342(a)(4). The firm's own testing also showed Listeria species positives. Investigators observed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), including failure to employ appropriate quality control, protect work-in-process from contamination, ensure employee hygienic practices, exclude pests, and maintain buildings in repair. Additionally, several products, including "Bel Capri Garlic Spread" and "Italian Style Flavored Bread Crumbs," were misbranded under 21 U.S.C. § 343 (21 CFR Part 101) for failing to declare major food allergens (milk, soy, wheat), provide complete ingredient lists with sub-ingredients, and for false or misleading labeling (declaring butter when not used). The firm initiated a recall and reported corrective actions, including hiring consultants and performing deep cleaning and swabbing. However, FDA requested more detailed information and scientific justification for these actions. The company must respond within 15 working days with specific corrective steps and documentation, or face potential regulatory action, including seizure, injunction, and re-inspection fees.