FDA 483 - Wacker Biotech GmbH

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.