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?
- Contact us for more information.