FDA EIR - Unknown Company - June 16, 2023

An FDA surveillance inspection of Biogen International GmbH, a foreign biologic drug substance API manufacturer, was conducted from June 12-16, 2023, in Luterbach, Switzerland. The inspection was performed under regulatory frameworks including 7356.002M (Surveillance Inspections of Protein Drug Substance Manufacturers) and ICH Q7 (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients). The scope covered Quality, Production, Facilities and Equipment, Material, and Laboratory Systems.

The inspection verified that deficiencies noted in a previous March 2022 inspection, which resulted in a Form 483 with four observations concerning vendor qualification, reference standard traceability, microbial control assurance, and microbial validation data, had been corrected.

During the current inspection, no new Form 483 observations were issued. However, three verbal observations were discussed with management: incorrect working cell bank lot expiry in batch records, Corrective and Preventive Actions (CAPAs) remaining in pending assignee evaluation since July 2022, and employees being overdue for training. Biogen's management was cooperative and promised to implement corrections for these issues. The FDA classified this inspection as 'No Action Indicated' (NAI), indicating routine follow-up.