Introduction

The Food and Drug Administration (FDA) Bioresearch Monitoring Program (BIMO) oversees FDA-regulated research by performing site visits to clinical investigators, sponsors, Institutional Review Boards (IRBs) and non-clinical animal laboratories. Site visits help to assure that human subjects and animals are protected from undue hazards and to verify that research data supporting new human and animal product approvals are reliable. 
FDA conducts inspections to determine if investigators are in compliance with FDA regulations. Inspections can be announced or unannounced. Most inspections are routinely performed to verify data submitted to FDA (e.g., at sites enrolling the largest number of subjects), but can also occur as a result of a complaint made to FDA, due to sponsor concerns, as a result of a review division request within FDA, or based upon current and ongoing public health issues.

Preparing for an Inspection

Investigators should take the following actions when notified that an on-site inspection by FDA is going to occur: 

  • Determine the nature (i.e., “for cause,” routine, etc.) and the scope of the audit. What protocols will be reviewed? How long will the FDA inspector(s) be on-site?
  • Routine inspections are generally scheduled within ten (10) working days of the initial contact and cannot be postponed without sufficient justification. 
  • Inform the following groups (as applicable) when initially contacted by FDA so that each party can prepare for the visit, as necessary: 
    • Research team and ancillary support services (e.g., pharmacy etc.)
    • School of Medicine Clinical Research Office (SOM CRO) 
    • Department Chair
    • IRB-HSR
  • Schedule an appropriate room for the auditors. Provide the FDA inspector(s) with office supplies, access to a copier and fax machine, and a list of staff contact names and telephone/pager numbers.
  • Pre-review all research records (medical and regulatory), and make them available to the inspector(s) at the time of the site visit. Investigators must allow the FDA to access, copy and verify any case history and/or drug or device administration records made by the research team or others.
  • At the conclusion of the site visit, the FDA inspector conducts an exit interview with the principal investigator and associated research team members. A written “Notice of Inspection” (Form FDA 483) is typically generated if deficiencies are found.
  • Forward a copy of post-audit communications and/or FDA Form 483 to the research team, Department Chair, IRB-HSR and the School of Medicine Clinical Research Office. Consult with SOM-CRO staff for assistance in responding to audit findings.

For more information about FDA site inspections, consult the FDA Compliance Program Guidance Manual. 

Additional Resources