• French Regulator Charged with Manslaughter for Role in Diabetes Drug Scandal

    • 22 March 2013
    French regulators have announced that judicial authorities have indicted the agency for its role in the regulation of the anti-diabetes drug Mediator, once manufactured by Servier and since blamed in the deaths of hundreds of French citizens. Background Mediator has been a drug plagued by scandal in recent years. A 2007  review  of the medication by the European Medicines Agency found that the use of the drug was dangerous in patients with high blood levels ...
  • CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive

    The US Food and Drug Administration's (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner of Zinnanti Surgical Design, for selling devices to hospitals in violations of current Good Manufacturing Practices (cGMPs). According to a 15 May statement released by DOJ, Zinnanti Surgical Design manufactured a non-sterile surgical device used primarily in hospital setting...