FDA EIR - Biogen International GmbH - June 16, 2023

A Food and Drug Administration (FDA) surveillance inspection of Biogen International GmbH, a biologic drug substance manufacturer in Luterbach, Switzerland, was conducted from June 12 to June 16, 2023. This pre-announced inspection, adhering to FDA guidance 7356.002M and ICH Q7, assessed the company's quality, production, facilities and equipment, material, and laboratory systems. The inspection confirmed that all four deficiencies noted during a prior March 2022 inspection, concerning vendor qualification, reference standard documentation, microbial control assurance, and microbial validation data, had been corrected. While no formal FDA Form 483 observations were issued, three verbal observations were discussed. These included an incorrect working cell bank lot expiry in batch records, corrective and preventive actions (CAPAs) pending assignee evaluation since July 2022, and employees being overdue for training. Biogen management was cooperative and committed to rectifying these points. The inspection concluded with a "No Action Indicated" (NAI) classification, requiring routine follow-up.