# GlaxoSmithKline, LLC. – FDA 483

Source: https://www.keypedia.com/records/483/glaxosmithkline-llc/427c278a-7412-4790-98d4-0aeb7758cc30

> FDA 483 for GlaxoSmithKline, LLC. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline, LLC.
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of GlaxoSmithKline, LLC in Conshohocken, PA, a drug substance manufacturer, revealed two significant observations. The firm lacked adequate controls for computerized systems, specifically regarding user access and audit trail review for bag integrity testers. Additionally, laboratory controls were found inadequate due to a lack of individual identification and traceability for microbiological control plates used in bioburden testing.

## Related Documents

- [483 - 2024-09-25](https://www.keypedia.com/records/483/glaxosmithkline-llc/2e61f4bb-ceab-409d-9c7e-ad3739096580) — date: September 25, 2024
- [483 - 2018-01-25](https://www.keypedia.com/records/483/glaxosmithkline-llc/d1a3cd11-06e2-4ab5-81cb-47552bfe467a) — date: January 25, 2018

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

Company: https://www.keypedia.com/companies/glaxosmithkline-llc/7ab59069-93ea-4898-a74a-874992c27286

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8