FDA 483 - Dynavax GmbH

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.