# FDA 483 - Dynavax GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/dynavax-gmbh/1002c9d5-8c2d-49e9-ab3d-f98eb7d518fa

> FDA 483 for Dynavax GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dynavax GmbH
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/dynavax-gmbh/8b6cc673-f4c0-4c1f-8dd0-6a7ac4137267)

## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.keypedia.com/companies/dynavax-gmbh/3c69b2a7-44b1-4674-8038-963c355c138f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4