# FDA 483 - GlaxoSmithKline Biologicals SA - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/glaxosmithkline-biologicals-sa/2460b5ec-845d-4add-905f-e53591d5c1f2

> FDA 483 for GlaxoSmithKline Biologicals SA on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals SA
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: GlaxoSmithKline Biologicals SA, a vaccine manufacturer in Rixensart, Belgium, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate laboratory controls, insufficient investigation into Water for Injection contamination, deficient corrective actions, and poor equipment maintenance. These issues indicate a need for improved quality systems and adherence to manufacturing standards.

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Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-biologicals-sa/ef569005-49c7-4bf9-b3f1-7814705bec8e

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