FDA WARNING_LETTER - Medline Industries, LP - December 12, 2025

On March 25, 2026, the FDA issued a Warning Letter to Medline Industries, LP, following an inspection of its NAMIC Division facility in Glens Falls, NY, conducted between December 1 and December 12, 2025. The inspection focused on the manufacturing of cardiovascular procedure kits, specifically NAMIC brand angiographic control syringes and manifolds. Under the Federal Food, Drug, and Cosmetic Act, the FDA determined these devices were produced under conditions that do not meet Quality System regulations. Main violations included a failure to implement adequate corrective and preventive actions (CAPA). Specifically, the firm received over 200 complaints regarding syringes disconnecting from manifolds—leading to serious risks such as air embolisms and biohazard exposure—but failed to take actions commensurate with these risks. Additionally, the FDA found that manufacturing cleanrooms were poorly maintained, with visible dust and particulate buildup on equipment linked to over 100 complaints of foreign matter in sterile products. The company also failed to provide sufficient design verification data for various connector components. Medline must provide a written response within 15 business days detailing its plan to correct these systemic issues and prevent their recurrence. The FDA noted that while the inspection occurred under previous standards, all future corrective actions must comply with the recently effective Quality Management System Regulation (QMSR). Failure to address these deficiencies promptly may result in regulatory actions, including product seizures, injunctions, or civil penalties.