Inspections, Compliance, Enforcement, and Criminal Investigations
OCI protects the public health and furthers the FDA mission by investigating suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and other related laws.
OCI has the primary responsibility for criminal investigations conducted by the FDA and for all law enforcement and intelligence issues pertaining to threats against FDA-regulated products. OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health.
Our priorities include:
1. Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products.
2. Criminal violations in situations where the normal regulatory process has been unable to remedy the problem.
3. 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.
4. 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