Sharing Our Experience with Our First Post-COVID‒19 Pandemic FDA GCP Inspection

Abstract

We recently underwent an FDA inspection. Because the previously scheduled FDA inspection was canceled due to the COVID-19 pandemic, it had been quite a while since we had an FDA inspection. Here, we report the details of this valuable experience to share it with other clinical trial sites in Japan. Although the inspection covered general check items, some areas were thoroughly examined from a risk-based perspective. No issues were identified during this inspection.