Synexus Clinical Research US, Inc. – FDA EIR, Feb 5, 2014

This FDA inspection report details an examination of Radiant Research in Pinellas Park, Florida, conducted from February 3 to February 5, 2014. The inspection was an initial assessment of the bio-clinical facility, requested by the Division of Bioequivalence and GLP Compliance, Office of Scientific Investigations. It specifically focused on Protocol #BTNF 1104, a study evaluating the safety and bioequivalence of a generic butenafine HCl cream compared to a reference listed drug and a vehicle control in treating interdigital tinea pedis. The inspection followed the regulatory framework outlined in CP 7348.001 and an assignment memo dated October 8, 2013. A thorough review of study documentation, subject records, and drug accountability procedures was performed. Notably, the inspection concluded with "no reportable observations," indicating full compliance with regulatory standards. During the close-out meeting, management confirmed no questions or concerns. As a result, no main violations or issues were identified, and no specific corrective actions were required from Radiant Research. A sample of the study drugs was collected by the investigators as part of the process.