FDA 483 - Baxalta US Inc. - April 07, 2022

An FDA inspection of Baxalta US Inc. in Thousand Oaks, CA, identified significant deficiencies in their manufacturing processes for sterile drug products. The firm's aseptic process validations, specifically media fills, were found to be inadequate, failing to accurately simulate commercial production conditions and interventions. Additionally, investigations into unexplained discrepancies and batch failures were insufficient, often not extending to other affected batches or being closed in a timely manner.