Pharmaceutical Company Subject of DOJ Sting, Story, Page 7

Byline 1/19/2010, Legal Times DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal, compliance or risk-management leadership role inside an FDA-regulated company, and unless you’ve been living under a rock, you are aware that the Obama Administration, the Department of Justice and the Food and Drug Administration are on the...
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Audits, Assessments & Corporate Compliance Investigations

Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready for any and all types of review by the FDA, Department of Justice or other regulator.  Audits, Assessments, Corporate Compliance Investigations and (one additional item) Mock Inspections are generally defined...
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Regulatory Alert: Customs’ Import Filing Program

January 26 is the deadline for compliance with the Customs Border Protection Importer Security Filing (ISF) program.  The following Regulatory Alert provides more details on this new program.  If your company imports products or materials into the United States, it is important that you are aware of the provisions of this program.   Penalties for non-compliance can be stiff, and can mount on...
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