# FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - March 15, 2019

Source: https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/d826d0ff-2abb-4e17-978e-118bec3fad2e

> FDA 483 for GlaxoSmithKline dba Human Genome Sciences Inc on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline dba Human Genome Sciences Inc
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of GSK's drug substance manufacturing site in Rockville, MD, revealed significant issues with quality oversight and adherence to written procedures. The firm failed to correct errors in executed production records for liquid drug substance manufacturing. Additionally, written procedures were not followed during manufacturing operations, including improper sample collection and inadequate equipment cleaning.

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## Related Officers

- [Jennifer Swisher, Ph.D.](https://www.keypedia.com/people/jennifer-swisher-phd/6c426abb-c3ae-42eb-8446-7f281137f87f)
- [issuing_officer](https://www.keypedia.com/people/scott-d-nichols/6cf9d198-7591-4f7c-984d-79b68a983c20)
- [Andrea Siegel](https://www.keypedia.com/people/andrea-siegel/7436ec58-8c64-4ad9-a6cf-7c2039c51447)
- [Shadia Zaman](https://www.keypedia.com/people/shadia-zaman/c534a993-7a9b-401e-bfe7-b209a916cf6e)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

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-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0