# Wacker Biotech GmbH – FDA 483

Source: https://www.keypedia.com/records/483/wacker-biotech-gmbh/b5ba45e5-0bc5-4895-9602-0bf9e1164f3c

> 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: Office of Medical Device and Radiological Health Operations
- Summary: During an inspection of Wacker Biotech GMBH in Jena, Germany, a drug substance manufacturer, the FDA observed that the manufacturing process for a drug substance did not consistently adhere to the process description detailed in the firm's submitted application. This non-conformance involved discrepancies in the use of materials and preparation of solutions for purification. The finding indicates a significant deviation from established regulatory expectations for manufacturing process control.

## Related Officers

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

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

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