FDA EIR - Novum Pharmaceutical Research Services - December 08, 2016

An FDA inspection was conducted at Novum Pharmaceutical Research Services in Fargo, ND, from December 7 to December 8, 2016. This routine inspection, carried out under Compliance Program 7348.001, aimed to assess the bio-pharmaceutics clinical research facility's adherence to regulatory standards. The inspection focused on a specific clinical study, reviewing various aspects including subject informed consent, adherence to the study protocol, accuracy of subject records, and accountability of test articles. Personnel interviewed included the Vice President and QA Manager. A thorough review of facility operations, standard operating procedures, and clinical data management systems was performed. Importantly, the inspection concluded with "no objectionable conditions" being identified. This outcome indicates that Novum Pharmaceutical Research Services was found to be in full compliance with applicable regulations, demonstrating robust quality systems and operational integrity in its clinical research activities. Consequently, no violations were cited, and no corrective actions were required by the FDA. This positive finding reflects the facility's commitment to maintaining high standards in pharmaceutical research.