FDA EIR - Frontage Clinical Services, Inc.

The FDA conducted an inspection of Frontage Clinical Services, Inc., a clinical investigator testing facility in Secaucus, NJ, from October 15 to 19, 2018. This inspection, directed by CDER, focused on a specific bioequivalence study (RMG-COL-PK001) for an investigational new drug application (NDA 210942), operating under regulations governing clinical trials. Although a formal FDA-483 was not issued, the inspection highlighted several areas for management discussion and improvement. Main issues included the absence of a clear Standard Operating Procedure (SOP) for a second reviewer to sign document logs when the primary reviewer was involved in the activity, as observed with a urine pregnancy test log. Management was advised to update SOPs to define reviewer succession and consider staffing levels. Another key point was the need to revise the definition of Adverse Events in study protocols to align with federal regulations (21CFR312.50). Minor protocol deviations, such as blood draws outside scheduled times, were noted but adequately documented. Additionally, inconsistent signing of site monitoring logs by the sponsor's monitor was observed. Management agreed to address these points, including consulting with the sponsor and CDER regarding the appropriate retention period for investigational product samples.