# FDA 483 - Bavarian Nordic Berna GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/bavarian-nordic-berna-gmbh/2c6d1575-178d-481f-bd66-7b69090ec8dd

> 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, an oral vaccine manufacturer, identified two observations related to incomplete validation activities. Specifically, the firm failed to complete shipping validation for a drug product and validation of the drug supply chain security for a packaging line. These issues indicate potential deficiencies in quality control and supply chain management.

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## Related Officers

- [Gregory Price](https://www.keypedia.com/people/gregory-price/02de7ef4-4bc4-44cd-bfad-c1da5aa9a943)
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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