# FDA 483 - Biotest AG - Unknown Date

Source: https://www.keypedia.com/records/483/biotest-ag/7faa4316-e912-4d34-a254-1552abadfa42

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biotest AG in Dreieich, Germany, was inspected by the FDA from December 4-15, 2023, regarding its drug substance and drug product manufacturing, specifically for Yimmugo. The inspection revealed significant deficiencies across multiple areas, including inadequate quality oversight, poor deviation management, insufficient contamination controls, and deficient process validation. These issues indicate a lack of robust control over manufacturing processes and documentation, potentially impacting product quality and purity.

## Related Officers

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd