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Ten Percent of Clinical Inspections Led to Warning Letters in 2011

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Onsite inspections of clinical investigators triggered by referrals experienced an upswing in 2011. At the same time, the FDA offered some important clues for clinical sites wondering how likely they are to receive an onsite inspection.

A regulatory requirement for institutional review board (IRB) registration that went into effect in July 2009 partially explains the large jump in onsite inspections of clinical investigators triggered by referrals. For fiscal 2010, complaints or referrals led to 91 investigator inspections according to FDA’s Office of Scientific Investigation. Data audits triggered the rest.

OSI began to receive significantly more reports of noncompliance from IRBs in 2010. The inspections were conducted by CDER’s Bioresearch Monitoring Program (BIMO).

Don’t let your next inspection catch you unprepared! Every year the FDA tweaks its inspection processes and policies, and if you aren’t on board you might be warned next.

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