FDA EIR - Celerion Inc. - June 05, 2019

An FDA surveillance inspection of Celerion Inc. in Tempe, AZ, was conducted from May 28 to June 5, 2019. This routine inspection, falling under the Bioresearch Monitoring Compliance Program (CP 7348.003), focused on adherence to Good Clinical Practices (GCPs) for two specific study protocols, reviewing subjects’ records, test article management, and sample handling. The inspection's primary finding was that no FDA-483, Inspectional Observations, were issued to Celerion Inc. at its conclusion, indicating a general compliance with regulatory expectations during the review period. However, one notable observation was that blinding envelopes for Protocol # (b) (4) were not maintained at the facility, having been returned to the study sponsor. The firm indicated a new internal process would be implemented to store randomization schedules within the regulatory binder to address such documentation. During the inspection, an FDA investigator collected a sample of retention drug products (Sample # 1086473) for Protocol # (b) (4). The facility demonstrated no refusals of inspection procedures, and all discussions with management concluded without further issues. This report confirms the site's overall compliance and its proactive step to improve documentation practices regarding randomization schedules.