FDA WARNING_LETTER - NYWP Enterprise LLC. - October 30, 2014

The FDA inspected NYWP Enterprise LLC, a multiple food warehouse, from October 15-30, 2014, identifying significant violations of Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). These deficiencies caused food products to be adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations included a severe lack of pest control, with active rodent nests, carcasses, excreta, gnaw marks, and birds observed throughout the facility, landing on and defecating on food. The firm also failed to maintain proper plumbing and floor drainage, leading to standing water, and improperly used rodenticides near food. Facility construction and design were inadequate, with multiple pest access points and insufficient precautions against contamination. Poor exterior drainage created pest harborage, and improper storage of equipment and waste attracted pests. Aisles were obstructed, preventing inspection for pest activity. Single-service articles were stored under a leaking roof, and unprotected light fixtures were over exposed food. Additionally, employees were observed smoking while handling food products. The firm's November 19, 2014, response to the FDA-483 was deemed unacceptable due to a lack of supporting documentation for corrective actions. The FDA requires a written response within 15 working days detailing specific corrections and preventing recurrence, with documentation. Failure to comply may result in regulatory actions like seizure, injunction, and re-inspection fees.