FDA 483 - Janssen Biotech, Inc. - May 18, 2026

During an inspection, Janssen Biotech, Inc. in Malvern, PA was cited for incomplete written records of investigations. Specifically, the firm failed to adequately investigate out-of-specification batches of Bovine APO Transferrin and a decrease in process capability for API Pre-formulated Bulk Bioactivity Assay. These issues indicate deficiencies in the firm's quality control unit and investigation procedures.