FDA 483 - Fresenius Kabi USA LLC - February 17, 2025

Fresenius Kabi USA LLC, a sterile drug manufacturer in Melrose Park, IL, received a Form 483 citing significant deficiencies across multiple areas. The observations highlight inadequate investigations into critical product defects like foreign particulates and sterility failures, insufficient validation of visual inspection methods, and widespread failures in aseptic processing controls. Repeated issues with environmental monitoring, aseptic technique, and equipment maintenance indicate a systemic lack of control over sterile drug manufacturing processes.