FDA 483 - Baxalta Manufacturing Sarl

An FDA inspection of Baxter Bioscience Manufacturing Sarl in Neuchatel, Switzerland, revealed significant deficiencies in quality control and manufacturing processes for its Advate lyophilized final drug product. The firm released multiple lots of product affected by unexplained discoloration without completing investigations or assessing patient safety. Additionally, the inspection found inadequate complaint investigations, insufficient release and stability testing, and procedures that failed to ensure product quality after out-of-specification results or unknown residues in equipment.