# FDA 483 - GSK Vaccines GmbH - March 06, 2024

Source: https://www.keypedia.com/records/483/gsk-vaccines-gmbh/17a156b1-1d2c-45e5-a69d-7e981fede4f2

> FDA 483 for GSK Vaccines GmbH on March 06, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GSK Vaccines GmbH
- Inspection Date: 2024-03-06
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: GSK Vaccines GmbH in Marburg, Germany, was cited for significant deficiencies during an FDA inspection. Observations included failures in preventing microbiological contamination of sterile drug products, inadequate investigation of discrepancies, and poor material segregation. Additionally, the firm was found to have incorrect expiration dates on drug product containers and accompanying documentation.

## Related Documents

- [483 - 2024-03-06](https://www.keypedia.com/records/483/gsk-vaccines-gmbh/1df7d112-ac75-45f8-aed1-e1e3b1ae54d2)
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## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/gsk-vaccines-gmbh/af5a9fae-fd5f-4aad-b88d-666e8cf72794

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321