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Compliance with OIG, CIA and beyond

Companies that have entered into Settlement Agreements with the federal government may be subject to a Corporate Integrity Agreement (CIA). CIAs require that companies file annual reports to the OIG and may also require an on-site visit by the OIG. Check whether the company is subject to a CIA, or any other requirements as a result of an enforcement action.

OIG Compliance Checklist

  • Is there a comprehensive compliance program in place?
  • Does it include the seven elements?
  • Has the Company or any Person been excluded or debarred from FDA or OIG?
  • System in place to check semi-annually status on OIG and FDA lists
  • Compliance with state reporting (VT, MN, CA)
  • Is there a report of any violations of the code of conduct?
  • Define any “reportable events” (i.e., anything brought to the attention of senior management that a reasonable person thinks could be a violation of criminal, civil or administrative law)
  • If there are any reportable events, what corrective action has been taken?
  • Is there a confidential disclosure program (for overpayments or other issues)?
  • What systems are in place to track samples?