• Regulatory NewsRegulatory News

    FDA Warns Fresenius Kabi API Manufacturing Plant

    The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi's active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies. The warning letter, sent 18 December and following an eight-day inspection in April 2017, raises questions about Fresenius' failure to adequately address a sterility failure. FDA sa...
  • Regulatory NewsRegulatory News

    FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution. FDA first approved Fenwal's new drug application (NDA) for InterSol (500mL platelet additive solution 3) in 2009 as a storage solution to replace a portion of the plasma in platelets collected via the company's Amicus apheresis devi...