# FDA 483 - Novartis Pharmaceuticals A. G. - March 23, 2017

Source: https://www.globalkeysolutions.net/records/483/novartis-pharmaceuticals-a-g/95eed813-4402-4e22-af93-ce08daa2e048

> FDA 483 for Novartis Pharmaceuticals A. G. on March 23, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals A. G.
- Inspection Date: 2017-03-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Novartis Pharmaceuticals A. G. in Broomfield, CO, revealed significant deficiencies in pharmacovigilance practices. The firm failed to timely report numerous serious and unexpected adverse drug experiences to the FDA, with some reports being significantly delayed. Additionally, investigations into these late submissions were found to be inadequate, lacking proper root cause analysis and preventive actions.

## Related Officers

- [Fenrin Jangchup](https://www.globalkeysolutions.net/people/fenrin-jangchup/8ee5fa1c-4b96-4717-a86f-aedc73d8b822)
- [Jamie L. C. Dion](https://www.globalkeysolutions.net/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.globalkeysolutions.net/companies/novartis-pharmaceuticals-a-g/b2132cf4-c297-41c1-a339-73dc2dea8f65

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face