Under certain circumstances, FDA may choose to inspect the electronic service vendors,
such as when they are or were engaged in providing services and functions that fall under
areas regulated by FDA. For example, if the criticality of the investigation requires
inspection and the required records are not available from the sponsor or the clinical
investigation site, FDA may choose to inspect records specific to the clinical
investigation at the vendor’s facilities to ensure that FDA requirements are met. The
sponsor or other regulated entity is ultimately responsible for ensuring that regulated
records and data are available to FDA during an investigation or an inspection.