# FDA 483 - Bavarian Nordic Berna GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/bavarian-nordic-berna-gmbh/c356daf8-9023-4501-95a5-e2ad381e54f9

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

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## Details

- Record Type: 483
- Company Name: Bavarian Nordic Berna GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of PaxVax Berna GmbH in Thörishaus, Switzerland, revealed significant deficiencies in quality control and manufacturing practices. Observations included inadequate investigations into foreign material and out-of-specification results, insufficient cleaning validation for freeze dryers, and poor oversight of adverse event reporting. These issues indicate potential risks to product quality and patient safety.

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- [483 - 2017-09-22](https://www.keypedia.com/records/483/bavarian-nordic-berna-gmbh/95741743-2c93-4e26-9016-df2994a77737)
- [483 - 2018-12-06](https://www.keypedia.com/records/483/bavarian-nordic-berna-gmbh/89ddb6fc-77c3-44a0-bb5a-e97b866059e3)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bavarian-nordic-berna-gmbh/2c6d1575-178d-481f-bd66-7b69090ec8dd)

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)

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

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