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 issued a warning letter to an API manufacturer in Gujarat, India for using untested water in manufacturing and for invalidating an out-of-specification test result without justification. Read More
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release. Read More
The FDA’s Office of Prescription Drug Promotion issued a warning letter to Metuchen Pharma over misleading claims in a print advertisement for its erectile dysfunction drug Stendra (avanafil). Read More