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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. Read More
The FDA and Centers for Disease Control and Prevention have advised healthcare facilities to strictly adhere to manufacturers’ instructions for reprocessing medical devices, as reports of improperly cleaned instruments continue to surface. Read More