FDA 483 - Baxalta US Inc.

BAXALTA US, INC. (TAKEDA) in Thousand Oaks, CA, a manufacturer of biologic drugs, APIs, and combination drug/devices, received an FDA Form 483 citing multiple significant deficiencies. These included inadequate investigations into failed media fills, poor aseptic practices, ineffective cleaning and disinfection, and untimely reporting of serious adverse events for several drug products. The observations highlight systemic issues in quality control, environmental monitoring, and deviation management, impacting the assurance of product sterility and overall patient safety.