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.
The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More