Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 8.9 - OFFICE OF CRIMINAL INVESTIGATIONS (OCI)
The Office of Criminal Investigations (OCI) has the primary responsibility for all criminal investigations conducted by the FDA, including suspected tampering incidents and suspected counterfeit products. Similarly, OCI has primary responsibility and is the primary point of contact for all law enforcement and intelligence issues pertaining to threats or perceived threats against FDA regulated products. OCI participates in numerous law enforcement and intelligence task forces both nationally and internationally to include a full time representative to Interpol.
All reports of suspected or confirmed criminal activity, including suspected tampering or counterfeiting incidents, must be reported to the appropriate OCI field office or resident office without delay. Additionally, all threats or perceived threats against FDA regulated products are to be referred immediately to the local OCI Field Office or to OCI Headquarters. In those instances where OCI does not, or cannot, initiate a criminal investigation in a timely manner, the District Offices will determine, in consultation with OCI, the proper follow-up.
OCI is the FDA's liaison component with the law enforcement community for criminal investigations and related matters. In addition OCI serves as the primary point of contact between the FDA and the Intelligence Community on all matters of mutual interest. All contacts regarding requests or questions received from federal, state, or local law enforcement agencies or intelligence agencies are to be referred without delay to the local OCI Field Office. Similarly, contacts to FDA Headquarters or Centers should be referred to OCI Headquarters. When FDA personnel receive information or requests from law enforcement or other agencies, they should obtain the caller's name, organization, and request and then refer the caller to the appropriate OCI component. After referring the caller to OCI, contact the affected OCI unit to provide them with the caller's information. This will ensure OCI is not caught by surprise. FDA personnel should not respond to inquiries concerning criminal investigations, including questions seeking confirmation of whether FDA is or is not conducting a criminal investigation.
OCI has been designated the authority to administer the consensual electronic surveillance program for the FDA. To comply with FDA Policy and Department of Justice requirements, all FDA personnel must contact the appropriate OCI Field Office SAIC to request approval before any electronic surveillance; this includes recording consensual telephone conversations. FDA Headquarters and Center personnel should contact OCI Headquarters, AD IOD for approval requests.
OCI is also the point of contact for any request for a mail cover through the U.S. Postal Inspection Service. A mail cover provides a written record of all data appearing on the outside of any class of mail to obtain information for:
- Protecting national security;
- Locating a fugitive; and
- Obtaining evidence of the commission or attempted commission of a crime punishable by more than one year in prison. A mail cover may not be used in non-criminal investigations, except in those cases involving a civil forfeiture of assets related to violations of criminal laws.