The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Sun Pharmaceuticals’ Caraco unit may resume some of its Detroit and Wixom, Mich., operations after recent FDA inspections show it is in compliance with a 2009 consent decree. The decree relates specifically to production of Caraco’s heart failure drug carvedilol and antibiotic paramomycin. Drug Industry Daily