483
MedLine Industries, LP (NAMIC Division)FDA 483 - MedLine Industries, LP (NAMIC Division) - December 12, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- New York District Office
- Person
Open in Dashboard
ID · 1c126746-5a6c-4141-86c0-084683082201