# FDA 483 - Bavarian Nordic A/S - November 07, 2023

Source: https://www.keypedia.com/records/483/bavarian-nordic-as/8a4eb3ac-1049-4f96-a9eb-8f375dee9fbe

> FDA 483 for Bavarian Nordic A/S on November 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bavarian Nordic A/S
- Inspection Date: 2023-11-07
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Bavarian Nordic A/S, a vaccine manufacturer in Kvistgard, Denmark, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures to thoroughly investigate discrepancies and complaints, inadequate equipment maintenance, and deficiencies in aseptic processing simulations and environmental monitoring procedures. The firm also lacked proper visual inspection of reserve samples and failed to ensure data accuracy in computer systems.

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## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/bavarian-nordic-as/c5568360-841f-40cc-a482-d0fe7d40b4e1

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917