Josefa Binker, M.D.July 25, 2019

FDA 483 - Josefa Binker, M.D. - July 25, 2019

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Record Details

An FDA inspection of Josefa Binker, M.D., a clinical investigator in Homestead, FL, revealed significant issues with adherence to investigational plans. The inspection found that subjects were enrolled in studies without meeting the specified inclusion and exclusion criteria, indicating a failure to properly conduct clinical investigations. This could compromise the integrity and reliability of the study data.

Company: Josefa Binker, M.D.
Inspection Date: July 25, 2019
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Kathryn L. Suttling (issuing_officer)

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ID · 06dda451-5315-4ed9-8774-6f3fb4fce96e