Medline Industries, Inc. – FDA Warning Letter, Oct 14, 2025

Medline Inc. received an FDA warning letter following an inspection of its Waukegan, Illinois facility from October 6 to 14, 2025. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211, rendering the company’s drug products adulterated. The primary issues involve the repeated detection of Bacillus cereus contamination in drug products and the manufacturing environment since 2023. Medline failed to thoroughly investigate these microbiological failures or implement effective corrective and preventive actions (CAPA). Additional violations include inadequate facility design, poor aseptic practices by personnel, and failures in cleaning and disinfecting manufacturing equipment. The FDA emphasized that previous remediation attempts were insufficient and that similar issues have occurred at other company sites. Medline is required to provide a comprehensive risk assessment of contamination hazards, a detailed remediation plan for manufacturing and cleanroom design, and an independent review of its investigation and CAPA systems. Furthermore, the company must evaluate sterilization options, such as transitioning to terminal sterilization, to ensure product safety. Failure to address these deficiencies promptly may lead to legal action, such as product seizures or injunctions, and could impact the approval of future drug applications.