1. Pink Sheet

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
DOJ and FDA attorneys note what would trigger breach of compliance provisions in deferred prosecution agreements • Source: Shutterstock

Attorneys from the US Department of Justice and 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).

“There may be screw ups. Frankly, we’re sort of expecting that because [given] the reality of manufacturing and corporate life, we know that that there will be mistakes that are...

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