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483
•Hagop M. Kantarjian, M.D.•May 5, 2017

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

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Record Details

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.

Company
Hagop M. Kantarjian, M.D.
Inspection Date
May 5, 2017
Product Type
Drugs
Office
Dallas District Office
Person
  • Alanna L. Mussawwir-Bias (Assistant Country Director, Regulatory Specialist BIMO)
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ID · ede3cc71-0ef1-46b5-908a-e128be222fff

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