# FDA 483 - GlaxoSmithKline Biologicals SA - February 27, 2026

Source: https://www.keypedia.com/records/483/glaxosmithkline-biologicals-sa/317a6754-c193-40b0-9072-9f4d2412a735

> FDA 483 for GlaxoSmithKline Biologicals SA on February 27, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals SA
- Inspection Date: 2026-02-27
- Product Type: biologics
- Office Name: Office of Partnerships
- Summary: GlaxoSmithKline Biologicals SA in Wavre, Belgium, a vaccine manufacturer, was cited for significant deficiencies in its manufacturing processes and controls. Observations included failures in computer system accuracy checks, use of non-validated manufacturing parameters, inadequate aseptic process validation, and insufficient environmental monitoring in sterile production areas. These issues indicate a lack of robust quality control and adherence to established procedures, potentially impacting drug product quality and sterility.

## Related Officers

- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/glaxosmithkline-biologicals-sa/9a234513-4162-49b8-b149-5c1be5aa9090

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3