# FDA 483 - Bavarian Nordic Berna GmbH - September 22, 2017

Source: https://www.globalkeysolutions.net/records/483/bavarian-nordic-berna-gmbh/95741743-2c93-4e26-9016-df2994a77737

> FDA 483 for Bavarian Nordic Berna GmbH on September 22, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bavarian Nordic Berna GmbH
- Inspection Date: 2017-09-22
- Product Type: biologics
- Office Name: Division of Advertising & Promotion 
- Summary: PaxVax Berna, a vaccine/drug manufacturer in Thörishaus, Switzerland, was inspected by the FDA from September 15-22, 2017. The inspection revealed significant issues related to unvalidated lyophilization process changes and a failure to file appropriate supplements for these changes. Additionally, the firm had deficiencies in its procedures and practices for evaluating adverse events and technical complaints.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

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

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0