# FDA 483 - Dynavax GmbH - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/dynavax-gmbh/8b6cc673-f4c0-4c1f-8dd0-6a7ac4137267

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

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## Details

- Record Type: 483
- Company Name: Dynavax GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Dynavax GmbH, a bulk drug substance manufacturer in Dusseldorf, Germany, was inspected by the FDA from January 26 to February 03, 2023. The inspection revealed one observation concerning inadequate investigations into out-of-specification test results. Specifically, the firm failed to adequately review the sanitization processes of manufacturing equipment during these investigations.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd