FDA EIR - Unknown Company - June 16, 2023

Biogen International GmbH, located in Luterbach, Switzerland, underwent a surveillance inspection by the FDA from June 12-16, 2023. The inspection focused on its biologic drug substance Active Pharmaceutical Ingredient (API) manufacturing operations, adhering to regulatory frameworks 7356.002M and ICH Q7. The inspection covered various systems including quality, production, facilities, equipment, materials, and laboratory. The firm had successfully corrected four deficiencies from a previous March 2022 inspection, which related to inadequate vendor qualification, insufficient reference standard documentation, microbial control assurance, and microbial validation data.

During the most recent inspection, no formal FDA Form 483 observations were issued. However, three verbal observations were noted: an incorrect working cell bank lot expiry in batch records, Corrective and Preventative Actions (CAPAs) that had been pending evaluation since July 2022, and overdue employee training. Biogen management was cooperative and committed to implementing corrections for these issues. The FDA concluded the inspection with a "No Action Indicated (NAI) - routine follow up" classification, signifying that no immediate regulatory action is required beyond the firm's promised corrective measures.