Iilun Murphy, the director of the US Food and Drug Administration’s Office of Generic Drugs (OGD), issued a warning to manufacturers regarding a recently identified leachable nitrosamine in certain drug products that are packaged in infusion bags.
She stressed that manufacturers of affected products must conduct thorough risk assessments to confirm that their bags do not contain this substance. These risk assessments are required to be completed by 16 November 2025.
I am just coming back from CPHI Frankfurt, where I had the opportunity to talk to many API, Excipient and CMOs… I am seriously worry about the lack of awareness there is about the criticality of nitrosamines for many of them. Many are just waiting for a regulatory agency to showed up and ask about it, to then take actions… is that what it will take?
That’s True, as a private label auditor i see the same attitude even at finished product manufacturers where i am using all my time and sources to make them aware of the actual situation and impact they are going to have if they didn’t perform a proper risk assessment.