FDA 483 - Nephron Pharmaceuticals Corp. - August 17, 2012

Nephron Pharmaceuticals Corp., an aseptic fill drug manufacturer in Orlando, FL, was cited for three observations during an FDA inspection. Deficiencies included the quality control unit not following procedures for annual product reviews and field alert reports, inadequate line clearance activities, and a failure to conduct routine re-qualification training for analytical lab employees. These issues indicate a lack of adherence to established written procedures across multiple operational areas.