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Home » Cane S.p.A Gets Warning Letter Over Infusion Pump Procedures
Cane S.p.A Gets Warning Letter Over Infusion Pump Procedures
The FDA handed Italian devicemaker Cane S.p.A. a warning letter for not including a software validation procedure in a Form 483 response, after the agency determined that production of the Crono S-PID-50 infusion pump did not comply with current good manufacturing practices.