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  1. Inspections, Compliance, Enforcement, and Criminal Investigations

Investigative Priorities

Investigative Priorities

FDA Agents Guard Public Health - OCI Badge - (JPG)

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.