Medline: Following FDA Warning Letter, Prior Inspections, and Recalls Related to Contamination, Company Receives FDA 483 Over Microbial Testing Practices at Mundelein Facility

In the wake of recent FDA scrutiny of microbial contamination in Medline (MDLN) products and several related recalls, FDA investigators found during a July inspection that the company has substandard processes for testing drug products for microbial contamination at its Mundelein, Illinois facility, according to a Form 483 inspection report obtained by The Capitol Forum

Published on Sep 21, 2026

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