# FDA 483 - Biotest AG - June 20, 2025

Source: https://www.keypedia.com/records/483/biotest-ag/3703851a-3b2c-4aed-a463-d35ce9cccc58

> FDA 483 for Biotest AG on June 20, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biotest AG
- Inspection Date: 2025-06-20
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

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## Related Officers

- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [Hoda Ehat](https://www.keypedia.com/people/hoda-ehat/5005baba-048c-4b27-a06b-8c803f96b66d)
- [Sergey S. Akimov](https://www.keypedia.com/people/sergey-s-akimov/4eca8d78-ef17-49a7-aaa1-5fa8fecf0383)

Company: https://www.keypedia.com/companies/biotest-ag/a9ea8ef4-79ad-47e6-a0a9-c434d0a69869

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4