Moore Clinical Research Inc.March 5, 2015

FDA 483 - Moore Clinical Research Inc. - March 05, 2015

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Record Details

During an inspection of Moore Clinical Research Inc. in Brandon, FL, the FDA observed a significant protocol deviation at this biopharmaceuticals clinical facility. An investigation was not conducted in accordance with the investigational plan, specifically regarding subject enrollment criteria. A subject was consented and randomized into a study despite being underage according to the protocol's inclusion criteria.

Company: Moore Clinical Research Inc.
Inspection Date: March 5, 2015
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Gene R. Gunn (investigator)

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ID · 4c537e9f-1742-47e5-8e96-c4c2e2f0f5ff