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Compliance In Focus
Posted by Stephani Hulec on Fri, Jan 17, 2014

FDA Audit Prep

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of FDA Audit Preppanic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit.  It is helpful for a site to know what the FDA auditor will use during their review.  In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations.

The blog also discussed how the FDA’s BIMO checklist may be utilized to prepare for an audit.  The BIMO checklist for clinical investigators is a great tool for the site to utilize during their audit prep process.  The FDA Compliance Program Guidance Manual (CPGM), uses this downloadable manual as a guide when conducting audits of clinical investigator and sponsor-investigator sites.

If all goes well with your audit, your FDA inspection will conclude with no findings.  However, as we in the field know, auditors may document what they feel are significant findings in an inspectional observations Form 483.  A list of FDA Form 483 frequently asked questions  is a helpful guide to understand the purpose of this form.  Once issued a Form 483, investigators are required to submit a formal written response to the auditor.  In another IMARC blog, we discussed the importance of a site’s written response to a Form 483 in correlation with a subsequent warning letter.  As noted in the blog, there have been numerous times when a clinical investigator has received a warning letter from the FDA, based in their inadequate or inappropriate responses to the Form 483.  It is important to note that the FDA takes the site’s corrective action plans seriously, and may or may not issue a warning letter, based on whether or not the response to the Form 483 was deemed adequate.

There is no need to wait for “the call” to prep for an audit – we believe preparation should occur from Day One.  Read the BIMO checklist and consider your studies and how they would fare if the FDA came knocking.

What other advice can be given for sites to prepare themselves if notified of an audit?

Photo Credit:Ari Herzog

Drugs & Devices Trial Guideline

Topics: Form 483, Audit Prep, BIMO Checklist, FDA


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