Dynavax GmbH

FDA 483 - Dynavax GmbH

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Record Details

During an inspection from January 26 to February 03, 2023, Dynavax GmbH, a Bulk Drug Substance Manufacturer in Dusseldorf, Germany, was cited for an inadequate investigation into an out-of-specification endotoxin test result. The investigation failed to properly evaluate the sanitization cycle and its re-qualification, indicating deficiencies in their quality control processes.

Company: Dynavax GmbH
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Operations
Person: Susan M. Jackson (investigator)

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ID · 1002c9d5-8c2d-49e9-ab3d-f98eb7d518fa