FDAnews Device Daily Bulletin

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