FDA
Audits
The OQC assists teams who have been notified they have been selected, or informed
that there is a high likelihood they will be selected, for an FDA audit.
Support, resources, and services are provided to research teams by the OQC.
Inform OQC of FDA inspection notification
Research Teams are required to notify OQC and CRSO when they received notice of an impending FDA audit.
The OQC provides the following support to all institutional research:
- Educating investigators and research teams on proper audit conduct
- Attending opening, daily, and closing meetings with the inspector and research team
- Providing guidance throughout the audit.
- Assisting with audit findings and writing responses to an FDA 483, if issued.
- Creation and follow-up of the corrective action plan, if necessary.