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.
A generic drug manufacturer in the Bahamas drew a warning letter from the FDA and was placed on an import alert for cGMP violations at its Freeport City facility, including inadequate validations and testing. Read More
The FDA named Indian drugmaker Torrent Pharmaceuticals as a target of its investigation into nitrosamine impurities and issued the company a warning letter for repeat violations at its Indrad, Gujarat plant. Read More
The FDA issued a warning letter to Indian API and generics manufacturer Glenmark for multiple violations at its Baddi, Himachal Pradesh plant, including incomplete investigations of complaints. Read More