# FDA 483 - GlaxoSmithKline Vaccines Srl - January 26, 2024

Source: https://www.globalkeysolutions.net/records/483/glaxosmithkline-vaccines-srl/b8d0d4ba-6250-4324-906b-df120af9e87f

> FDA 483 for GlaxoSmithKline Vaccines Srl on January 26, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Vaccines Srl
- Inspection Date: 2024-01-26
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: GlaxoSmithKline Vaccines Srl in Sovicille, Italy, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate discrepancies and batch failures, including high invalid test rates for vaccine assays and unaddressed stopper coring complaints. Additionally, the quality control unit did not fully follow procedures, employees lacked required training, and adverse drug experiences were not reported to the FDA within the mandated timelines.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-vaccines-srl/3b442668-2065-481f-bc35-a803bb376acc

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