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

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

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