FDA 483 - MedLine Industries, LP (NAMIC Division) - December 12, 2025

MedLine Industries, LP (NAMIC Division) in Glens Falls, NY, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate corrective and preventive actions for critical product issues, insufficient equipment maintenance and cleaning, incomplete MDR reporting, and failures in process and design validation. These issues pose risks related to product quality, patient safety, and regulatory compliance.