# FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - Unknown Date

Source: https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/06180595-cb3e-4947-86f4-5a753f6134fb

> FDA 483 for GlaxoSmithKline dba Human Genome Sciences Inc on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline dba Human Genome Sciences Inc
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Human Genome Sciences, Inc. in Rockville, MD, a drug substance intermediate manufacturer, received a Form 483 with three observations. The inspection revealed issues with the manufacturing process, including undocumented repeated steps and non-conforming batch numbering. Additionally, the firm failed to follow written procedures for deviation reporting and investigation, and employees were not adequately trained prior to performing manufacturing operations.

## Related Documents

- [483 - 2013-04-26](https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/928ba880-1b8c-4356-831e-0f16d2c1f4dd)
- [483 - 2019-03-15](https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/d826d0ff-2abb-4e17-978e-118bec3fad2e)
- [483 - 2023-12-11](https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/845ffa38-5805-4d93-95b8-ff8e8d207fcf)
- [483 - 2025-07-31](https://www.keypedia.com/records/483/glaxosmithkline-dba-human-genome-sciences-inc/1bd342b5-73d7-4968-9da2-73fae2cb4d50)

## Related Officers

- [Xiaoshi Wang](https://www.keypedia.com/people/xiaoshi-wang/8249ff14-dec6-4ffd-9893-bdf8ba6af7ce)
- [investigator](https://www.keypedia.com/people/thuy-thanh-nguyen/8e2e9be6-8d27-45d9-a3b0-cf3e9a0eb3c4)
- [Anjali A Shenkle](https://www.keypedia.com/people/anjali-a-shenkle/fba72bff-22dd-46a7-8545-4513a5544b4b)
- [issuing_officer](https://www.keypedia.com/people/amy-a-devlin/fed31d2d-96d0-4849-a167-92bec5d6d2be)

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

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