# FDA 483 - GlaxoSmithKline Biologicals - August 05, 2025

Source: https://www.keypedia.com/records/483/glaxosmithkline-biologicals/f4700203-4f06-44a9-98fe-2286cfb2f588

> FDA 483 for GlaxoSmithKline Biologicals on August 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals
- Inspection Date: 2025-08-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: GlaxoSmithKline Biologicals in Singapore received a Form 483 for significant deviations in manufacturing sterile bulk drug substance. Observations included inadequate sterility testing procedures that deviated from their approved BLA, incomplete investigations into particle contamination and alarm system outages prior to product release, and a failure to timely submit a Biological Product Deviation Report for glass fragment contamination. These issues affected multiple batches of Hiberix drug product released to the U.S. market.

## Related Documents

- [483 - 2022-11-08](https://www.keypedia.com/records/483/glaxosmithkline-biologicals/85579657-07cf-4b48-a742-2251d873b77a)
- [483 - 2022-11-08](https://www.keypedia.com/records/483/glaxosmithkline-biologicals/606188b7-5f5e-4977-9606-59a6e8e0fa6d)
- [483 - 2025-08-05](https://www.keypedia.com/records/483/glaxosmithkline-biologicals/a79cc271-e4bb-49fd-8611-358008b339d4)

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/glaxosmithkline-biologicals/a1983e6a-fbe9-4c98-8efb-39f62ca09624

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8