# FDA 483 - GSK Vaccines GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/gsk-vaccines-gmbh/23ea82dd-cdb6-49e7-857d-3f90a9c7d456

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GSK Vaccines GmbH in Marburg, Germany, identified significant deficiencies in the manufacture of Shingrix and Measles bulk drug substances. Observations included poorly maintained facilities and equipment, inadequate qualification and monitoring of critical utilities, and a lack of quality oversight for electronic data and deviation management. These issues raise concerns about the identity, strength, quality, and purity of the drug substances produced.

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd