FDA 483 - Biogen U.S. Corporation - August 26, 2022

An FDA inspection of Biogen U.S. Corporation in Research Triangle Park, North Carolina, revealed significant deficiencies in preventing microbiological contamination during sterile drug product manufacturing. The firm also lacked adequate procedures to ensure drug product quality through visual inspection and failed to specify timeframes for in-process sample testing. These observations indicate a need for improved aseptic processing controls, a more robust visual inspection system for particulates, and clearer timeframes for sample testing.