FDA EIR - Altasciences Clinical Kansas Inc. - September 19, 2017

An FDA inspection of Vince & Assoc Clinical Research, located in Overland Park, KS, was conducted from September 13 to September 19, 2017. This high-priority Bioresearch Monitoring (BIMO) inspection focused on a bioequivalence study involving investigational products PF-06438179 and Infliximab, under the regulatory framework of CP 7348.001. The inspection encompassed various aspects of clinical research operations, including chart audits, informed consent forms, source document verification against electronic Case Report Forms, drug reconciliation, and reserve sample collection. A significant outcome of this assessment was that no objectionable conditions or significant concerns were identified, and consequently, no FDA Form 483, Inspectional Observations, was issued to the firm. The report noted that a previous discussion item from a January 2017 inspection, regarding documentation improvements, had been successfully addressed. As part of the closing procedures, three reserve samples (595990, 595991, 595992) were collected. Management was reminded of its ongoing responsibility to adhere to regulatory compliance, and the potential consequences of non-adherence were discussed and acknowledged. The overall recommendation for this inspection was "No Action Indicated," reflecting the firm's satisfactory compliance with applicable regulations.