Medline Industries - Arlington Heights – FDA 483, Feb 6, 2026
An FDA inspection of Medline Industries - Arlington Heights revealed significant deficiencies in their quality system regarding the control and investigation of nonconforming medical devices. The firm failed to adequately identify, contain, and rework potentially defective Aquapak Prefilled Humidifiers, leading to their shipment to customers. Additionally, investigations into nonconformities were often not conducted or lacked adequate rationale, indicating a systemic breakdown in their corrective and preventive action processes.
- Office
- Chicago District Office
- Person
ID · c3080023-1d41-4799-9eee-a1cc5ca48071
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