Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

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Three recent settlements demonstrate the DOJ’s continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act and the threat of criminal prosecution via a deferred prosecution agreement, DOJ prosecutors continued their efforts to hold companies accountable for conduct that poses a risk to patient health and safety. FDA-regulated companies should review these settlements to gain a better understanding of what conduct is likely to trigger enforcement scrutiny, and companies should take steps to enhance internal quality and compliance controls to prevent problems in the first instance and to promptly identify and remediate quality and manufacturing problems when they do occur.

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