Amidst a rising tide of FDCA criminal enforcement, FDA cautions companies to remain mindful of CGMP data integrity


It has become difficult for FDA-regulated companies to ignore, in recent years, the potential fallout of violating current Good Manufacturing Practices (cGMPs). After making clear that cGMP compliance would be a top focus of regulatory and criminal enforcement, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have been true to their word, with a range of highly visible enforcement activities, from administrative actions (such as Warning Letters) to civil judicial actions (including seizures, consent decrees, and civil penalties) to a number of criminal prosecutions. That this emphasis on cGMP will continue and is likely to increase in the near term was underscored during the Food and Drug Law Institute’s recent annual conference: Members of the FDA bar urged drug and device companies to heed lessons from civil and criminal actions taken this year in the food context (against cheese company Roos Foods, Inc.) for alleged cGMP-related adulteration—especially in an environment where federal prosecutors are perhaps more empowered than ever.

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