# FDA 483 - GSK Vaccines GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/gsk-vaccines-gmbh/f889ba90-a909-4729-bb37-4bb0b8217254

> FDA 483 for GSK Vaccines GmbH on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GSK Vaccines GmbH
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of GSK Vaccines GmbH in Marburg, Germany, revealed six observations concerning the manufacture of Shingrix and Measles bulk drug substances. Key issues include deficient maintenance of facilities and equipment, inadequate qualification and monitoring of critical utilities, and significant lapses in quality oversight for electronic data integrity and deviation management. These findings indicate a lack of control over critical manufacturing processes and potential risks to product quality.

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## Related Officers

- [Holly Brevig](https://www.keypedia.com/people/holly-brevig/68a8fca4-e80e-40f2-9ecc-4b4bcfcd8d1d)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)
- [other](https://www.keypedia.com/people/shuang-tang/d395d86d-ffe1-4650-919a-f91029a1c376)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4