In this white paper, Thompson FDA focuses on six areas of recent enforcement activity that have revealed the government’s priories as it identifies companies and corporate officials for investigation, brings civil and criminal actions against those companies and individuals, and seeks 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.