During an FDA inspection, what will inspectors primarily focus on?

During an FDA inspection, inspectors primarily focus on the review of regulatory records. This is essential to ensure compliance with established regulatory requirements and guidelines. Inspectors meticulously evaluate records to verify that the clinical trial has been conducted according to the approved protocol, that data has been accurately reported, and that participant safety and informed consent processes have been appropriately managed.

Regulatory records include a broad range of documentation such as informed consent forms, source documents, case report forms, and any relevant correspondence. These records serve as a foundation for the FDA’s assessment of how well the clinical study adheres to Good Clinical Practice (GCP) standards and other regulatory obligations.

While inspectors might issue warning letters or recommend protocol changes if they find significant issues, the core activity during an inspection revolves around reviewing these records. The determination of whether an assurance should be restricted could be a consequence of findings from the record review, but it is not the primary focus during the inspection itself.