FDA 483 - Biotest AG - June 20, 2025

An FDA inspection of Biotest AG in Dreieich, Germany, a manufacturer of Fibrinogen DS and DP, revealed significant deficiencies across multiple quality system areas. Observations included the misuse of temporary deviations, inadequate aseptic control and cleanliness practices, poor facility and equipment maintenance, and insufficient cleaning validation and assay design. These issues indicate a lack of robust quality oversight and control over critical manufacturing processes.