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.
Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the FDA’s Form 483 inspection observations. Read More
The FDA issued a warning letter to a South Korean OTC manufacturer Dermameal for violations at its facility in Gyeonggi-do, including the incomplete quality testing and an inadequate stability program. Read More
Fort Worth drugmaker CBI Laboratories was slapped with a Form 483 for multiple violations at its facility including a flawed quality unit, the lack of annual product reviews and a failure to conduct cleaning validations. Read More