# FDA 483 - Hagop M. Kantarjian, M.D. - May 05, 2017

Source: https://www.globalkeysolutions.net/records/483/hagop-m-kantarjian-md/ede3cc71-0ef1-46b5-908a-e128be222fff

> FDA 483 for Hagop M. Kantarjian, M.D. on May 05, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hagop M. Kantarjian, M.D.
- Inspection Date: 2017-05-05
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Hagop M. Kantarjian, M.D. in Houston, TX, identified significant deficiencies in the conduct of clinical trials. Observations included the improper documentation of informed consent, where forms were not dated by subjects, and the failure to report adverse experiences to the study sponsor in a timely manner as required by protocol and regulations.

## Related Officers

- [Assistant Country Director, Regulatory Specialist BIMO](https://www.globalkeysolutions.net/people/alanna-l-mussawwir-bias/1283ff1a-34dd-4d90-9389-7bff2570527d)

Company: https://www.globalkeysolutions.net/companies/hagop-m-kantarjian-md/57a20198-e024-409a-b67e-d0b49222c3a9

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9