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GMP Violations Won’t Trigger Breach Of DOJ Compliance Agreement, Government Attorneys Say

 
• By Brenda Sandburg

Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.

Compliance
• Source: Shutterstock

Attorneys from the US Department of Justice and the Food and Drug Administration sought to ameliorate worries that medical product companies could be readily found in violation of compliance provisions in a deferred prosecution agreement (DPA) or non-prosecution agreement (NPA).

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More from Policy & Regulation

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