483
Dynavax GmbHDynavax GmbH – FDA 483
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
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ID · 1002c9d5-8c2d-49e9-ab3d-f98eb7d518fa
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