# FDA 483 - GlaxoSmithKline Biologicals Kft. - January 31, 2025

Source: https://www.keypedia.com/records/483/glaxosmithkline-biologicals-kft/ea27ad0a-a637-4b0d-a339-8b06f7455608

> FDA 483 for GlaxoSmithKline Biologicals Kft. on January 31, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals Kft.
- Inspection Date: 2025-01-31
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of GlaxoSmithKline Biologicals Kft. in Godollo, Hungary, a licensed biological drug manufacturer, revealed significant deficiencies in manufacturing investigations and material acceptance procedures. The firm failed to adequately investigate particulate contamination and temperature excursions, leading to the release of potentially compromised vaccine batches. Additionally, procedures for accepting components with particulate matter were found to be inadequate, lacking proper risk assessments.

## Related Documents

- [483 - 2025-01-31](https://www.keypedia.com/records/483/glaxosmithkline-biologicals-kft/b7349afb-33ba-469d-92f5-19f16080b357)

## Related Officers

- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/glaxosmithkline-biologicals-kft/3426122d-c02e-49e7-860c-6ff5237018d3

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