483
MedLine Industries, LP (NAMIC Division)MedLine Industries, LP (NAMIC Division) – FDA 483, Dec 12, 2025
Record Details
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.
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- New York District Office
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ID · 1c126746-5a6c-4141-86c0-084683082201
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