# FDA 483 - Kadmon Corporation, LLC - December 08, 2020

Source: https://www.keypedia.com/records/483/kadmon-corporation-llc/d6c40b1d-ae77-4e3b-88c3-78caba4d7d24

> FDA 483 for Kadmon Corporation, LLC on December 08, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kadmon Corporation, LLC
- Inspection Date: 2020-12-08
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Kadmon Corporation, LLC, a sponsor, was inspected in Cambridge, MA, from December 3-8, 2020. The inspection revealed a significant failure to promptly address a non-compliant clinical investigator in a Phase 2 clinical trial. This led to numerous issues including data integrity problems, patient safety concerns, and inadequate oversight of study conduct.

## Related Officers

- [Matthew C. Watson](https://www.keypedia.com/people/matthew-c-watson/a1594b84-f65a-42f9-a06d-a68a49eb4b28)

Company: https://www.keypedia.com/companies/kadmon-corporation-llc/9935c41c-7714-48c5-b460-e71d12adc56a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94