• EMA Warns of Potentially Contaminated Cancer Drug in Light of Manufacturing Deficiencies

    Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues. The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue. EMA officials said they had inspected Pacira'...
  • 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...
  • New Biologic Sterility Regulation Issued by FDA

    The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers and encourage the use of cutting-edge technologies to assure the safety of biological products. In its 2 May Federal Register posting entitled Amendments to Sterility Test Requirements for Biological Products , FDA said its rule is "intended to promote improvement and i...