# FDA 483 - Biotest AG - June 20, 2025

Source: https://www.keypedia.com/records/483/biotest-ag/a59facf0-3643-4bbe-a3bb-2f8a37468b13

> 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 Inspections and Investigations
- Summary: 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.

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## Related Officers

- [Sergey S. Akimov](https://www.keypedia.com/people/sergey-s-akimov/4eca8d78-ef17-49a7-aaa1-5fa8fecf0383)
- [Hoda N. Thai](https://www.keypedia.com/people/hoda-n-thai/7e17f660-1b4f-44ba-a4a1-ae425f98cd7f)
- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [Hooti, Ilat](https://www.keypedia.com/people/hooti-ilat/03f105ed-c4c8-4f00-9e29-8729fc596f7e)
- [Sergey, Simonov](https://www.keypedia.com/people/sergey-simonov/20e10212-81c8-4401-9079-7df9f2de0174)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8