FDA 483 - Medline Industries - Arlington Heights - February 06, 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.