FDA EIR - Chiltern International Inc - July 31, 2015

An FDA inspection of Chiltern International Inc., a contract research organization (CRO) based in Cary, NC, was conducted from July 27 to July 31, 2015. This was Chiltern's initial FDA inspection, specifically directed to evaluate compliance with research activities transferred from Novocure, Ltd., focusing on a particular (b)(4) protocol. The inspection was carried out under Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors.

The inspection concluded without disclosing any significant deficiencies, and consequently, a Form FDA 483, Inspectional Observations, was not issued. All site personnel demonstrated excellent cooperation, providing all requested information and answering questions thoroughly. While no formal violations were identified, a verbal observation was made regarding the importance of ensuring data accuracy in communications sent to clinical sites. This specific point was discussed with management but was determined not to affect subject safety or data integrity, thus not warranting a formal regulatory action. No immediate corrective actions were formally required from Chiltern International Inc. by the FDA at the conclusion of this inspection.