Triggers of an FDA Audit

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Jun 18, 2015

Triggers of an FDA Audit

Posted By:admin     /     Under: Clinical Trials Management Blog

The Food and Drug Administration has just walked through your office doors and announces that an audit is about to take place. How could this be? What happened to alert the FDA to visit your research site?

The FDA makes unannounced visits to research sites on a regular basis. Sometimes these inspections are simply routine in nature. However, the inspector could be showing up because somehow, a red flag was raised.

Triggers of a for-cause audit by the FDA include:

  • A complaint
  • Sponsor concerns
  • IRB concerns
  • Termination of a clinical site
  • Multiple deviations or adverse events
  • FDA identified special interest

Because these triggers are not planned, it is best practice to always be prepared for a visit from the FDA. This means keeping all documentation up to date and ready for inspection and holding regular meetings with your staff to discuss how to handle an audit. Your preparation could even include conducting a mock audit to prepare your staff should the FDA walk through the door.

But no matter how you prepare for such a visit, we encourage all research programs to be up to date on the FDA’s published information surrounding inspections.


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