# FDA 483 - GlaxoSmithKline Biologicals - November 08, 2022

Source: https://www.globalkeysolutions.net/records/483/glaxosmithkline-biologicals/606188b7-5f5e-4977-9606-59a6e8e0fa6d

> FDA 483 for GlaxoSmithKline Biologicals on November 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals
- Inspection Date: 2022-11-08
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GlaxoSmithKline Biologicals in Singapore revealed significant deficiencies in their quality system. Observations included inadequate documentation of investigations and CAPA effectiveness checks, improper identification of drug substance containers, and incomplete batch production and control records. These issues indicate a need for improved adherence to good manufacturing practices.

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

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

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