FDA 483 - Medline Industries, LP - July 18, 2025

Medline Industries, LP in Hartland, WI, a drug manufacturer, was inspected by the FDA from July 14-18, 2025. The inspection revealed significant deficiencies across various aspects of their drug manufacturing operations, including inadequate raw material identity verification, poor laboratory record-keeping, insufficient investigation of discrepancies, and lax control over labeling and computer systems. These issues indicate a lack of robust quality control and adherence to GMP regulations.