# FDA 483 - GlaxoSmithKline Biologicals - March 12, 2024

Source: https://www.keypedia.com/records/483/glaxosmithkline-biologicals/132ad59c-5f34-44cf-a334-a1cf5c633f04

> FDA 483 for GlaxoSmithKline Biologicals on March 12, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals
- Inspection Date: 2024-03-12
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: GlaxoSmithKline Biologicals in Saint-Amand-Les-Eaux, France, was inspected regarding its Shingrix vaccine manufacturing. The inspection revealed significant deficiencies including delayed investigation of vial defects, inadequate equipment cleaning procedures, and failures in both reserve sample examination and timely adverse event reporting. These issues indicate a lack of thorough quality control and compliance with regulatory reporting requirements.

## Related Documents

- [483 - 2022-09-13](https://www.keypedia.com/records/483/glaxosmithkline-biologicals/0ee61d1c-710e-4da3-aaa7-198abf7c893c)
- [483 - 2024-03-12](https://www.keypedia.com/records/483/glaxosmithkline-biologicals/9e7e7917-0ccb-407d-a24c-5f2e85efb021)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.keypedia.com/companies/glaxosmithkline-biologicals/98ade6fb-8ae1-48af-a7cf-71b26cd2e808

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