Inspections, Compliance, Enforcement, and Criminal Investigations

About OCI

OCI Best Badge

As FDA’s criminal law enforcement arm, OCI protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.

Since 1993, OCI has investigated thousands of criminal schemes involving a broad range of criminal conduct, including

  • Distribution of foreign counterfeit, unapproved, and misbranded medical products
  • Major organized illicit diversion of prescription drugs
  • Fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures
  • Large-scale product-substitution conspiracies
  • Application and clinical investigator fraud, and
  • Health fraud involving FDA-regulated drugs and medical devices

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Expanding Footprint

In the summer of 1993, OCI opened three more offices in Chicago, New York and Metropolitan Washington, DC. After opening its six field offices in 1993, OCI added six resident offices and 26 domicile offices to become operational throughout the United States and Puerto Rico.

Today, OCI taps into the global network of law enforcement through its agents posted in Singapore (Interpol) and The Hague, The Netherlands (Europol).

Map of OCI Field and Resident Offices. For details contact OCI.

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OCI Special Agents

OCI Special Agents are dedicated to protecting the health and welfare of the public by investigating criminal allegations falling within FDA’s jurisdiction.

The agents employ a traditional law enforcement approach to the systematic collection of evidence necessary to ensure successful criminal prosecutions.

OCI special agents are experienced in using traditional law enforcement methods, professional contacts, and investigative techniques to bring their cases to a successful conclusion.

They have the authority to obtain and execute arrest and search warrants, carry firearms, and gather evidence to enforce U.S. criminal law.

And, while serving as OCI special agents, they receive continuing advanced instruction in FDA food and drug law, interviewing techniques, financial crimes, computer forensics, asset forfeiture, legal education, and Internet investigations.

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Investigative Support

The increasing globalization of crime has created new challenges to law enforcement. OCI’s investigative support personnel are trained and experienced in the latest techniques and technologies to support OCI’s investigations. FDA’s state-of-the-art Forensic Chemistry Center (FCC) conducts forensics analyses in support of OCI criminal investigations.

OCI provides its special agents with numerous resources to support investigations, including an experienced staff of investigative analysts, technical equipment specialists, polygraph examiners, information technology specialists, special agents trained in computer forensics.

In addition, the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, provides valuable forensic laboratory support by performing many different tests on products that are the subject of investigations.

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OCI’s Founding

In 1991, in the wake of a generic drug scandal, the FDA Commissioner announced the establishment of an Office of Criminal Investigations (OCI) within FDA.

This newly-created law enforcement office was created with the support and urging of the House Committee on Oversight and Government Reform. OCI was empowered to conduct and coordinate criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), the Federal Anti-Tampering Act (FATA), other related acts, and applicable violations of USC 18 (Crimes and Criminal Procedures).

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Establishing a National Presence

In March 1992, the formation of OCI began when FDA selected Terry Vermillion, a career federal law enforcement officer, to serve as the founding Director of this new law enforcement office. To accomplish this major undertaking, OCI selected experienced and trained managers, special agents, and technical and support staff from numerous federal law enforcement agencies and from within FDA.

In January 1993, OCI opened its first three field offices in Kansas City, Miami, and San Diego.

In the summer of 1993, OCI opened three more offices in Chicago, New York and Metropolitan Washington, DC. After opening its six field offices in 1993, OCI added six resident offices and 26 domicile offices to become operational throughout the United States and Puerto Rico.
 

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Page Last Updated: 03/12/2018
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