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GMP Inspectors Will Scrutinize Adverse Event Reporting Compliance

 
• By Elizabeth Crawford

Regular under-reporting of serious adverse event reports has spurred FDA to have its good manufacturing practice inspectors review dietary supplement firms’ AERs and reporting practices, FDA’s Fabricant says. Key compliance issues can tip off the agency that a company may be falling short on reporting.

With under-reporting of serious adverse events rampant, FDA’s good manufacturing practices inspections will look closer at dietary supplement firms’ compliance with AER regulations, said Division of Dietary Supplement Programs Director Dan Fabricant.

The agency, in turn, likely will increase enforcement actions against AER rule violations.

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