FDA EIR - Biogen International GmbH - June 16, 2023

A pre-announced surveillance inspection of Biogen International GmbH, a biologic drug substance Active Pharmaceutical Ingredient (API) manufacturer in Luterbach, Switzerland, was conducted by the FDA from June 12 to June 16, 2023. The inspection was carried out under regulatory guidelines including 7356.002M for protein drug substance manufacturers and ICH Q7 Good Manufacturing Practice for APIs. The inspection verified that deficiencies identified during a previous inspection in March 2022, concerning vendor qualification, reference standard documentation, microbial control assurance, and microbial validation data, had been corrected by the firm. During the current inspection, no formal FDA Form 483 observations were issued. However, three verbal observations were discussed with company management. These included an incorrect working cell bank lot expiry noted in a batch record, Corrective and Preventive Actions (CAPAs) that had been pending assignee evaluation since July 2022, and employees being overdue for required training. Biogen management demonstrated cooperation and committed to addressing these verbal observations. The inspection concluded with a classification of No Action Indicated (NAI), signifying that no immediate regulatory action is required, with routine follow-up anticipated. The firm continues to manufacture commercial biological Drug Substance for the US market.