FDA 483 - Medline Industries, Inc. - October 14, 2025

Medline Industries, LP in Waukegan, IL, was inspected and received a Form 483 with five observations indicating significant deficiencies in their quality control unit, manufacturing processes, and facility maintenance. The inspection revealed repeated microbial contamination issues, inadequate investigations, poor aseptic practices by operators, and failures in cleaning procedures and facility repair, all posing a risk to drug product quality and purity. The firm failed to ensure CGMP compliance and address systemic quality issues.