FDA EIR - David R. Hassman, DO - September 27, 2017

A surveillance inspection of Clinical Investigator David R. Hassman, D.O., operating as Comprehensive Clinical Research in Berlin, NJ, was conducted by the FDA from September 18 to September 27, 2017. The inspection, carried out under the regulatory framework of Clinical Investigators, CP 7348.811, aimed to assess compliance with applicable regulations and protocol for a Premarket NDA application. While no formal FDA-483, Inspectional Observations, was issued, management engaged in discussions regarding several key issues. These included the need for consistent progress notes in patient files to document procedures and conversations, and ensuring the delegation log accurately reflected study personnel titles and qualifications, as some roles were inconsistent with experience or other regulatory forms. Furthermore, the firm was advised to retain original carbon copies of all laboratory order sheets in subject files, and to report all protocol deviations, such as an unrecorded two-day out-of-window patient visit. Required actions involve implementing robust documentation practices, ensuring accuracy and consistency in personnel records, and maintaining complete original study data.