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483
•Moore Clinical Research Inc.•March 5, 2015

Moore Clinical Research Inc. – FDA 483, Mar 5, 2015

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)
View Company Profile

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

Other documents for Moore Clinical Research Inc.
  • 483 - 2013-04-02April 2, 2013

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