Trends in FDA Enforcement: An Update on Agency Policy, Civil Settlements, Consent Decrees and Criminal Prosecutions
As the nation and the world struggled to emerge from the COVID-19 pandemic, the FDA and the Department of Justice (DOJ) continued their unrelentingly vigorous scrutiny of companies regulated by the agency and pursued a range of civil and criminal enforcement actions targeting those that allegedly failed to comply with FDA mandates and other regulatory and legal requirements.
In this white paper, Thompson FDA focuses on seven areas of recent enforcement activity that have revealed the government’s priorities as it identified companies and corporate officials for investigation, brought civil and criminal actions against those companies and individuals, and sought civil and criminal penalties.
As always, compliance officials and corporate management at all levels in FDA-regulated companies must stay up to date with the government’s enforcement activity, assess their companies’ risk in light of that activity, and adjust their operations and corporate compliance programs as needed to prevent noncompliant activities within their organizations.

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