# FDA 483 - SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) - March 15, 2024

Source: https://www.keypedia.com/records/483/smithkline-beecham-pharma-gmbh-co-kg-dba-glaxosmithkline-biologicals/844c9c7a-b8f2-438a-8fe3-d89cb297cebc

> FDA 483 for SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) on March 15, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals)
- Inspection Date: 2024-03-15
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) in Dresden, Germany, revealed significant deficiencies in laboratory controls. The firm failed to establish scientifically sound test procedures for in-process materials and drug products, and improperly invalidated tests without conducting thorough investigations. These issues raise concerns about the quality and integrity of their vaccine manufacturing processes.

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/smithkline-beecham-pharma-gmbh-co-kg-dba-glaxosmithkline-biologicals/184bcdd6-8f25-45bf-b562-fcb41f6c48f7

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