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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Criminal Investigations
  4. Investigative Priorities
  1. Criminal Investigations

Investigative Priorities

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OCI priorities include:

  • Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products
  • Criminal violations in situations where the normal regulatory process has been unable to remedy the problem
  • Criminal violations where the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process
  • Criminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice.

 

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