Biogen U.S. Corporation – FDA 483, Oct 17, 2023

Biogen U.S. Corporation in Durham, NC, was cited for significant deficiencies during an FDA inspection, primarily concerning quality control and manufacturing processes for sterile drug products. The firm failed to thoroughly investigate unexplained discrepancies, particularly regarding toxin-producing microorganisms and environmental contamination. Additional issues included inadequate microbiological contamination prevention procedures, insufficient laboratory controls for microbial testing, lack of process validation for critical equipment, and unestablished procedures for handling product complaints, including chipped vials.