# FDA 483 - Wacker Biotech GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/wacker-biotech-gmbh/ff8d77c0-2fd5-485b-8949-84b148075bed

> FDA 483 for Wacker Biotech GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wacker Biotech GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Wacker Biotech GmbH in Jena, Germany, revealed that the drug substance manufacturing process did not consistently adhere to the description provided in the submitted application. Specifically, discrepancies were noted in the use of certain materials and the inclusion of all process steps, indicating a significant deviation from documented procedures. This suggests potential issues with process control and adherence to regulatory submissions.

## Related Officers

- [Willie Wilson](https://www.keypedia.com/people/willie-wilson/d7028341-a417-41c9-ac00-997bfda722bb)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/wacker-biotech-gmbh/2c8d35d6-1890-46a6-8fb6-ea203affeef4

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