FDA EIR - Hassman, David, DO - August 14, 2008

An FDA inspection was conducted at the facility of Hassman, David, DO, in Berlin, NJ, from July 30, 2008, to August 14, 2008. The inspection revealed numerous deficiencies in the conduct and oversight of clinical investigations. The primary issues identified involved significant deviations from study protocols across multiple subject numbers. These protocol deviations included failures to conduct required patient evaluations such as post-intravenous temperatures, baseline and end-of-treatment laboratory tests, and electrocardiograms. Issues also surfaced regarding the administration of prohibited antibiotics, incorrect intravenous dosing, and evaluations performed outside specified time windows. Furthermore, the inspection highlighted substantial problems with data integrity and record-keeping. Observations cited inaccurate or missing records pertinent to adverse event relationships, drug administration times, concomitant medication documentation, and critical study data like test-of-cure photographs and microbiological culture results. These findings suggest a systemic lack of adherence to regulatory requirements for clinical investigations, reflecting concerns about Good Clinical Practice standards. The company is expected to provide a detailed response addressing these observations and outlining corrective and preventive measures to ensure the integrity and reliability of future clinical trial data.