Weiner, Gilbert R.November 25, 2013

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

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Record Details

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.

Company: Weiner, Gilbert R.
Inspection Date: November 25, 2013
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Craig A. Garmendia (investigator)
Brunilda Torres

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ID · 9e24920c-65c3-44b0-b674-0a3b1ab43ed6