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.
Indian drugmaker Cadila Healthcare was slapped with an FDA warning letter for serious violations at its injectable drug manufacturing facility in Ahmedabad, including cross-contamination from non-dedicated equipment. Read More
The Danish Medicines Agency took action against a violative drugmaker by suspending its authorization to manufacture drugs and intermediates, following an inspection that revealed serious GMP violations. Read More