FDA 483 - Weiner, Gilbert R. - November 25, 2013

The FDA inspection of Gilbert R. Weiner, a clinical investigator in Aventura, FL, revealed significant deviations in the conduct of a clinical trial. Key findings included a failure to adhere to the investigational plan, inadequate maintenance of case histories, and issues with the informed consent process. These observations highlight serious deficiencies in protocol execution and documentation practices during clinical research.