# FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - December 11, 2023

Source: https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/845ffa38-5805-4d93-95b8-ff8e8d207fcf

> FDA 483 for GlaxoSmithKline dba Human Genome Sciences Inc on December 11, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline dba Human Genome Sciences Inc
- Inspection Date: 2023-12-11
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Humon Genomics Sciences, Inc. in Rockville, MD, revealed significant deficiencies in their drug substance manufacturing processes. Observations included inadequate microbial control, ineffective root cause analysis and CAPA implementation, and failures in data integrity and training procedures. Additionally, the firm lacked appropriate identity testing for raw materials and adequate control over manufacturing components.

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## Related Officers

- [Brian M. Janelsins](https://www.keypedia.com/people/brian-m-janelsins/6ae9b26e-5c53-4e67-a19a-2af3f30df039)
- [Teegan A. Dellibovi-ragheb](https://www.keypedia.com/people/teegan-a-dellibovi-ragheb/9a1d66fc-5b51-4001-9379-8187802307fb)
- [Wendy G. Tan](https://www.keypedia.com/people/wendy-g-tan/aad9c7d5-1a63-43b6-bc25-531b7f4475a9)

Company: https://www.keypedia.com/companies/glaxosmithkline-dba-human-genome-sciences-inc/c3dd2e54-125d-4d56-b0dc-18cb333074cc

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