# FDA 483 - Bavarian Nordic Berna GmbH - December 06, 2018

Source: https://www.globalkeysolutions.net/records/483/bavarian-nordic-berna-gmbh/89ddb6fc-77c3-44a0-bb5a-e97b866059e3

> FDA 483 for Bavarian Nordic Berna GmbH on December 06, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bavarian Nordic Berna GmbH
- Inspection Date: 2018-12-06
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of PaxVax Berna GmbH, a vaccine manufacturer in Thörishaus, Switzerland, revealed significant deficiencies across its quality systems. The firm failed to adequately test drug products for objectionable microorganisms, conduct thorough investigations into discrepancies and defects, and report biological product deviations within the required timeframe. Additionally, issues were noted with adverse event reporting procedures, environmental monitoring, labeling accuracy, and adherence to manufacturing protocols, indicating a need for comprehensive corrective actions.

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## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [CSO](https://www.globalkeysolutions.net/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

Company: https://www.globalkeysolutions.net/companies/bavarian-nordic-berna-gmbh/c041bdf1-c3d5-46c3-a216-02ad314f45e0

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