Chapter 5 – Food, Colors, and Cosmetics – Sub Chapters 537 – 567 In this section: Manual of Compliance Policy Guides Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Manuals Manual of Compliance Policy Guides Chapter 5 – Food, Colors, and Cosmetics – Sub Chapters 537 – 567 Compliance Manuals    Sub Chapter 537 –…

List of Application Integrity Policy (AIP) Committee Members and AIP Contact Persons(Updated May 9, 2018)  Center for Biologics Evaluation and Research Anna Flynn, phone 240-402-8936 Center for Devices and Radiological Health Linda Godfrey, phone 301-796-5654 Center for Drug Evaluation and Research William “Peter” Rickman, phone 240-402-8766 Karen Takahashi, phone 301-796-3191 Center for Food Safety and…

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,…

        Food and Drug Administration Office of Criminal Investigations   Two defendants also under indictment on state charges for murder AUGUSTA, GA:  Five men and a woman have been indicted in federal court, charged with operating a wide-ranging drug conspiracy that included mass production of pills and possession with intent to distribute a powerful…

        Food and Drug Administration Office of Criminal Investigations   A jury yesterday convicted Paul J. Elmer, the former CEO and owner of Pharmakon Pharmaceuticals Inc. (Pharmakon), of conspiracy to defraud the Food and Drug Administration (FDA) and nine counts of adulterating drugs, the Department of Justice announced today. Pharmakon was a Noblesville, Indiana,…

        Food and Drug Administration Office of Criminal Investigations    Company Allegedly Lied to Doctors and Public Health Care Benefit Programs About the Safety and Diversion Risks of Suboxone Film A federal grand jury sitting in Abingdon, Virginia, has indicted Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.) and Indivior PLC (Indivior) for…

        Food and Drug Administration Office of Criminal Investigations   A Houston, Texas, man was sentenced today to 360 months in prison for multiple conspiracy and tax charges, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division. On Nov. 14, 2018, a jury convicted Kenneth J. Coleman, 52,…

        Food and Drug Administration Office of Criminal Investigations   PROVIDENCE – A Veteran Affairs Medical Center nurse who admitted to tampering with and fraudulently obtaining morphine and other opioid prescriptions at the VA Medical Center in Providence has been ordered to serve 24 months in federal prison. Jared Scott, 35, of West Warwick,…

        Food and Drug Administration Office of Criminal Investigations   A Marquette, Michigan man pleaded guilty today to smuggling products into the United States using fraudulent shipping invoices, U.S. Attorney Matthew Schneider announced. Schneider was joined in the announcement by Special Agent in Charge William P. Conway, of the U.S. Food and Drug Administration’s…

      Food and Drug Administration Office of Criminal Investigations   Xu Jia Bao (aka Fred Xu), of Shanghai, China, was sentenced in Dallas yesterday to 18 months’ imprisonment and one year of supervised release in connection with a scheme to sell mislabeled dietary supplements, the Department of Justice announced today.  Xu, 48, is the principal…