FDA EIR - Novum Pharmaceutical Research Services - June 23, 2016

An FDA inspection of Novum Pharmaceutical Research Services, located in Fargo, ND, took place from June 22 to June 23, 2016. This routine inspection of the bio-pharmaceutics clinical research facility, which operates as one of three clinical sites for Novum, was carried out under the Fiscal Year 2016 CDER assignment memorandum and Compliance Program 7348.001. The scope of the inspection included a comprehensive review of two specific ANDA studies. Inspectors examined a wide array of operational aspects, such as subject records, informed consent procedures, adherence to Institutional Review Board protocols, test article accountability and storage, adverse event reporting, and the accuracy of case report forms. Personnel, including the Vice President and QA Manager, were present and cooperative throughout the two-day process. Crucially, the inspection concluded with no objectionable conditions identified, indicating full compliance with regulatory standards. No samples were collected, and no refusals were encountered. This positive outcome means that no violations or significant issues were observed during the inspection, and consequently, no specific regulatory actions or corrective measures were required for Novum Pharmaceutical Research Services.