FDA EIR - PPD, Inc., part of Thermo Fisher Scientific - May 21, 2021

An FDA inspection of PPD, Inc., a contract research organization in Wilmington, NC, was conducted from May 6 to May 21, 2021. This was a directed, for-cause inspection initiated by the Center for Device and Radiological Health (CDRH) to evaluate a specific medical device clinical trial, in accordance with CP 7348.810. The inspection covered PPD's role as a CRO for the study, including its relationship with the sponsor and clinical investigators.

No FDA Form 483, Inspectional Observations, was issued at the conclusion of the inspection. However, two items were verbally discussed with PPD management. First, the study was not registered with ClinicalTrials.gov. PPD determined it was not an "applicable clinical trial" because it was deemed non-interventional per 42 CFR § 11.22(b)(1). However, the approved informed consent form erroneously stated the study would be registered and results posted, which PPD attributed to an oversight. Second, PPD did not provide a brief explanation of its Non-Significant Risk (NSR) determination to the Institutional Review Board (IRB) for the device, as outlined in 21 CFR 812.2(b)(ii). PPD stated they considered the investigation exempt under current regulations and FDA guidance. Management was cooperative and receptive to the verbal observations, with no formal actions required, though the investigator noted this was not the Agency's final determination.