Intra-Cellular Therapies IncMarch 22, 2019

FDA 483 - Intra-Cellular Therapies Inc - March 22, 2019

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Record Details

INTRA-CELLULAR THERAPIES INC in New York, NY, was cited for significant deficiencies during an FDA inspection of its sponsor activities. The firm failed to ensure that investigations were conducted according to the investigational plan and protocols, specifically regarding the recording and reporting of prohibited concomitant medications and protocol deviations. Additionally, the firm did not ensure proper monitoring of studies or adequate reporting of adverse events by clinical investigators.

Company: Intra-Cellular Therapies Inc
Inspection Date: March 22, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
People: Diane C. Van Leeuwen (issuing_officer)
Ni A. Khin (issuing_officer)
Bei Yu (issuing_officer)
Iram R. Hassan (investigator)

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ID · 21e47403-04e8-4419-bb7d-203f2d9c6381