FDA 483 - Baxalta US Inc. - September 18, 2025

Baxalta US Inc., a plasma derivative manufacturer in Thousand Oaks, CA, received an FDA Form 483 following an inspection conducted from September 10 to September 18, 2025. The inspection identified two significant observations related to regulatory compliance and quality control. The first observation noted Baxalta's failure to submit Medical Device Reports (MDRs) within the mandatory 30-day period for malfunctions of the Mix2Vial device, a component of their Vonvendi combination product. Unreported incidents included several complaints of "Incomplete Diluent Transfer" and one "Defective Device" complaint. This indicates a gap in their adverse event reporting system for device-related issues. The second observation highlighted deficiencies in the batch production and control records, specifically the absence of proper identification for major equipment and lines used during manufacturing. Examples included incomplete equipment details in batch records for products like ADVATE® and BAXJECT III®. Baxalta is required to address these findings by implementing robust corrective actions, ensuring timely adverse event reporting and comprehensive manufacturing documentation to comply with regulatory standards.