Wacker Biotech GmbH – FDA 483
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.
- Company
- Wacker Biotech GmbH
- Product type
- drugs
ID · b5ba45e5-0bc5-4895-9602-0bf9e1164f3c
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