For 30 years, medical device manufacturers worldwide have relied on The GMP Letter to comply with FDA's interpretation and enforcement of cGMPs and the Quality System Regulation (QSR). In each issue, you get an update on regulations and guidances and learn which companies the FDA has inspected and what they've found. You also get links to 483s, warning letters, closeout letters, FDA policy notices, and many other reports to help make your quality assurance efforts a success.