FDA 483 - Biotest AG - June 20, 2025

An FDA inspection of Biotest AG in Dreieich, Germany, a manufacturer of Fibrinogen Drug Substance and Drug Product, revealed significant deficiencies across multiple quality system areas. The observations included inadequate deviation management, poor aseptic control, facility and equipment maintenance issues, and insufficient cleaning validation. These findings indicate a concerning lack of control over critical manufacturing processes and environmental conditions.