FDA Site Inspections

The U.S. Food and Drug Administration (FDA) conducts inspections to protect the rights, safety, and welfare of research study participants, verify the accuracy and reliability of study data, and assess compliance with FDA regulations for the conduct of clinical trials. FDA inspections, or audits, are in-person site visits performed on clinical investigators, study sponsors, or IRBs.

What kind of inspections does the FDA conduct of investigators?

The FDA conducts site inspections on FDA-regulated clinical trials to verify data submitted to the FDA and determine if investigators comply with FDA regulations and the protocol.

FDA inspections can be:

Announced or unannounced
Routine or for-cause
On studies that are open or closed
Study-specific or investigator-specific
Of a single study or multiple studies

Reasons for an FDA inspection of an investigator may include:

Routine surveillance
High-enrolling study site
Coinciding with the review of a marketing application
Based upon current and ongoing public health issues
As a result of complaints received
As a result of reports of non-compliance
Due to sponsor concerns
To verify the implementation of corrective actions following a previous inspection

How do investigators prepare for an FDA site inspection?

The investigator must carefully, thoroughly, and accurately document every aspect of the study to assure the FDA that the study data are accurate, that participant safety is protected, and that the investigator conducts the study in compliance with the regulations and the protocol. Routine monitoring is the most important tool to be prepared for an inspection at any time and to minimize findings.

Should an investigator receive a notification of an FDA inspection or if an FDA inspector shows up unannounced, the Northwestern University IRB Office has compiled the following resources to guide investigators and staff on navigating an FDA inspection from beginning to end.

HRP-1910 – FDA Site Inspection Guidance: This document contains a comprehensive and detailed guidance for a successful FDA site inspection. It includes recommendations, best practices, and what to expect upon receiving an inspection notification, preparing for an inspection, and during and after an inspection.
HRP-2020 – FDA Site Inspection Preparation Checklist: This template condenses the inspection preparation information found in the FDA Site Inspection Guidance into a general checklist of recommended steps to prepare for a n FDA inspection.
HRP-2021 – Inspection Request Tracking Log Template: This is a template that study teams may use, customize, or reference to track all requests made by an FDA inspector.

What can happen as a result of an FDA site inspection?

After a site inspection, if the inspector observes serious deficiencies, the inspector will issue a Form 483 during the exit interview, which outlines serious findings based on the regulations that require correction. Following the inspection, the investigator has the opportunity to respond in writing to the findings listed in the Form 483. If the investigator does not address the findings to the FDA’s satisfaction, or if the findings are egregious, the FDA may issue a Warning Letter, which they will publicly post on their website. These actions can delay or prevent product approval. It is therefore essential that study teams are always prepared for an FDA inspection.

Should investigators notify the IRB of an FDA site inspection?

Yes – notify all of the following IRB Office contacts upon receipt of any FDA inspection notification so we can prepare and assist study teams in case the inspector has IRB-specific requests:

IRB Compliance Unit (irbcompliance@northwestern.edu)
IRB Compliance Manager (alec.henderson@northwestern.edu)
For Biomedical Studies: Biomedical IRB Manager (lsikorski@northwestern.edu) and Main Biomedical Office (irb@northwestern.edu)

What information should investigators provide to the IRB after an FDA inspection?

If the FDA issues a Form 483: the PI must submit a copy of the Form 483, the PI’s draft or official response, and CAPA plans to the IRB via a Reportable New Information (RNI) application.
If the FDA does not issue a Form 483, but the inspection identified information that indicates participants were placed at increased risk of harm or that participants’ rights or welfare were adversely affected: the PI must submit a copy of the inspection report, the PI’s draft or official response, and CAPA plans to the IRB via a Reportable New Information (RNI) application.
If the FDA does not issue a Form 483 and the inspection did not identify information that indicates participants were placed at increased risk of harm or that the participants’ rights or welfare were adversely affected: the PI must inform the IRB Office of the outcome via email with a copy of the final report or written communication from the FDA inspector.

The IRB may decide to take additional action based on the outcome or findings of an FDA inspection.