# FDA 483 - GlaxoSmithKline, LLC. - January 25, 2026

Source: https://www.keypedia.com/records/483/glaxosmithkline-llc/d1a3cd11-06e2-4ab5-81cb-47552bfe467a

> FDA 483 for GlaxoSmithKline, LLC. on January 25, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline, LLC.
- Inspection Date: 2026-01-25
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of SmithKline Beecham (d.b.a GlaxoSmithKline), a Fermented Biotech API Manufacturer, identified two significant observations. The firm's Standard Operational Procedures (SOPs) were found to be incomplete, specifically lacking instructions for documenting and reviewing cell bank passages for Mepolizumab Drug Substance production. Additionally, the Hold Time Study for Buffers and Shelf-life Study for Medium were incomplete, with missing buffer names and discrepancies between study conclusions and batch record storage instructions for Mepolizumab shake flask medium.

## Related Documents

- [483 - 2024-09-25](https://www.keypedia.com/records/483/glaxosmithkline-llc/2e61f4bb-ceab-409d-9c7e-ad3739096580)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

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