# FDA 483 - GlaxoSmithKline LLC - March 18, 2016

Source: https://www.globalkeysolutions.net/records/483/glaxosmithkline-llc/238914f5-64c1-4be7-9325-283246782011

> FDA 483 for GlaxoSmithKline LLC on March 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline LLC
- Inspection Date: 2016-03-18
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of GlaxoSmithKline LLC's non-clinical laboratory in King Of Prussia, PA, revealed significant deficiencies in their quality assurance unit. The firm failed to ensure proper authorization and documentation for deviations from approved protocols and standard operating procedures. This included inadequate management review of training records, a lack of required email notifications for archived data, and insufficient record-keeping for archived record loans.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/ching-jey-george-chang/d5a6da4d-e37d-4d81-aa51-d1981c55dd2e)
- [Tahseen Mirza](https://www.globalkeysolutions.net/people/tahseen-mirza/abb624c9-0315-4604-aaf7-b7ed15fe51af)
- [issuing_officer](https://www.globalkeysolutions.net/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [investigator](https://www.globalkeysolutions.net/people/marcelo-o-mangalindan-jr/9fe13d26-0c5e-4559-be36-812970fa67ce)

Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-llc/40e36523-e6ba-4cde-956b-d130d902d7b6

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