FDA EIR - Erik A. Imel, M.D. - December 14, 2017

An FDA clinical investigator inspection of Dr. Erik A. Imel, M.D. in Indianapolis, IN, was conducted from December 11-14, 2017. The inspection, requested by the Center for Drug Evaluation and Research (CDER) and carried out under Compliance Program 7348.811 for Clinical Investigators and Sponsor-Investigators, focused on Dr. Imel's conduct of two clinical studies: Protocol UX023-CL201 (Phase 2, pediatric) and Protocol UX023-CL303 (Phase 3, adult). Both studies evaluated the investigational product KRN23 for X-linked Hypophosphatemia (XLH). The inspection thoroughly reviewed aspects such as protocol adherence, informed consent, data verification, Institutional Review Board (IRB) and sponsor communications, investigational product accountability, and staff training. Notably, the inspection concluded without the issuance of an FDA Form 483, "Inspectional Observations," indicating no significant regulatory violations. A minor issue identified during record review concerned the accuracy of labeling study documents, specifically a mislabeled worksheet. This discrepancy was promptly corrected on-site, and Dr. Imel's team acknowledged the importance of maintaining accurate documentation. No formal regulatory actions were required as a result of this inspection.