D & D Catering, Inc. – FDA Warning Letter, Apr 8, 2011

The FDA issued a Warning Letter to D & D Catering, Inc. following inspections in February and March/April 2011 at their ready-to-eat (RTE) sandwich manufacturing establishment. Environmental swabs and finished product samples tested positive for *Listeria monocytogenes*, rendering the food adulterated under 21 U.S.C. § 342(a)(1). The inspections also revealed serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), leading to adulterated products under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations included failures to: manufacture, package, and store foods to minimize microbial growth and contamination (21 CFR 110.80(b)(2)); maintain equipment and containers to prevent contamination (21 CFR 110.80(b)(7)); handle work-in-process to protect against contamination (21 CFR 110.80(b)(5)); hold perishable foods to prevent adulteration (21 CFR 110.80(b)(3)); ensure production procedures prevent contamination, including allergen cross-contamination (21 CFR 110.80); clean food-contact surfaces adequately (21 CFR 110.35(d)); ensure proper employee handwashing/sanitization (21 CFR 110.10(b)(3)); and exclude pests from processing areas (21 CFR 110.35(c)). The FDA noted that similar observations were made in past inspections, and previous corrective actions were deemed inadequate. D & D Catering, Inc. must promptly correct all violations and submit a written response within 15 working days detailing corrective actions and proposed timeframes. The FDA will verify corrections during a subsequent inspection, indicating significant compliance implications.