FDA 483 - Baxter Oncology GmbH - August 27, 2024

Baxter Oncology GmbH, a drug product manufacturer in Halle Westfalen, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures in aseptic process simulation, uncalibrated manufacturing equipment, unclear drug substance storage, deficient validation, non-adherence to SOPs, and inadequate facility and equipment maintenance, all impacting drug product quality and sterility assurance.