Medline Industries QS Violations Cited

A 12/1-12/12/2025 FDA inspection at the Medline Industries NAMIC Division facility in Glens Falls, NY, found Quality System Regulation violations in the firm’s manufacturing and assembly of numerous medical devices into cardiovascular procedure kits. A 3/25 Warning Letter says the specific violations were:

• failure to establish and maintain procedures for implementing corrective and preventive action;
• failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met; and
• failure to establish and maintain procedures for verifying the device design, with design verification staff confirming that the design output meets the design input requirements.

Medline was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.