FDA EIR - Nigel S. Key, M.B., Ch.B., F.R.C.P. - June 04, 2020

An FDA inspection of clinical investigator Nigel S. Key was conducted from June 3-4, 2020. This high-priority PDUFA inspection, assigned by CBER/OCBQ/DIS/BMB and performed under the regulatory framework of CP7348.811 for Clinical Investigators, aimed to evaluate the conduct of a specific research protocol. The inspection concluded with no significant deviations from regulatory requirements or study protocols being identified. Consequently, no FDA Form 483 (Inspectional Observations) was issued. A minor discrepancy was noted regarding study visit end dates between the sponsor's data listings and the site's source documentation for three subject visits. However, a subsequent review of the electronic Case Report Forms (eCRFs) confirmed the site had correctly entered the actual visit dates. During discussions with Dr. Key and his research team, these minor inconsistencies were addressed, and management was advised of the regulatory options available to the FDA for non-compliance, though no specific corrective actions were formally mandated in the report.