# FDA 483 - Biotest AG - Unknown Date

Source: https://www.keypedia.com/records/483/biotest-ag/09c91773-6e2d-479d-9ee2-b8605d55d432

> FDA 483 for Biotest AG on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biotest AG
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Biotest AG in Dreieich, Germany, was inspected by the FDA from December 4-15, 2023, regarding its drug substance and drug product manufacturing. The inspection revealed significant deficiencies in quality oversight, deviation management, process validation, environmental controls, and documentation practices for the Yimmugo drug product. These issues indicate a lack of adequate controls to ensure product identity, strength, quality, and purity.

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## Related Officers

- [Miriam M. Ngundi](https://www.keypedia.com/people/miriam-m-ngundi/3999979f-7a00-4d34-8aed-e4426351c99f)
- [Nicole M. Li](https://www.keypedia.com/people/nicole-m-li/cfffdaa1-4ed3-43a3-81fc-03ddc459c564)
- [Neetu Dahiya](https://www.keypedia.com/people/neetu-dahiya/eca2915a-15a1-4f2b-a32f-99515fdde490)
- [Lu Deng](https://www.keypedia.com/people/lu-deng/2d16f326-f067-4b7b-a8bd-d22f87281972)

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