A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
St. Jude Medical’s Penang, Malaysia, plant received a seven-observation Form 483 at the conclusion of a May 2011 CDRH inspection. The 483 cites multiple concerns with environmental control procedures followed in the facility’s cleanrooms. For example, dust had built up on cleanroom workbenches, and the facility manager in charge of cleaning the cleanrooms violated sterility by walking across a “non-clean” area in his shoe coverings before entering the cleanroom. The GMP Letter