# FDA 483 - GlaxoSmithKline, LLC. - September 25, 2024

Source: https://www.keypedia.com/records/483/glaxosmithkline-llc/2e61f4bb-ceab-409d-9c7e-ad3739096580

> FDA 483 for GlaxoSmithKline, LLC. on September 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline, LLC.
- Inspection Date: 2024-09-25
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of GlaxoSmithKline, LLC in Conshohocken, PA, revealed significant deficiencies in their drug substance manufacturing operations. The firm failed to ensure adequate controls against contamination, properly validate manufacturing processes, and conduct thorough investigations into discrepancies. Furthermore, issues with data integrity and overall Quality Unit oversight were identified, indicating a broad lack of GMP compliance.

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- [483 - 2026-01-25](https://www.keypedia.com/records/483/glaxosmithkline-llc/d1a3cd11-06e2-4ab5-81cb-47552bfe467a)

## Related Officers

- [Jun Liu, Ph.D., Senior Biologist](https://www.keypedia.com/people/jun-liu-phd-senior-biologist/b602698c-6139-4860-928f-1c7706da4b54)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)
- [Zhen Ren, Ph.D., Staff Fellow](https://www.keypedia.com/people/zhen-ren-phd-staff-fellow/00154253-06a4-42c5-bfe3-b887233c41fb)
- [Yi Wang, PhD, Staff Fellow](https://www.keypedia.com/people/yi-wang-phd-staff-fellow/5a38ae27-971d-41cc-be0f-7398c4228e7f)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/priscilla-amaral/40f8110f-e324-4583-b97c-4daacad0e299)

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