FDA 483 - Nephron Pharmaceuticals Corp. - June 17, 2011

Nephron Pharmaceuticals Corp. received a Form 483 citing multiple deficiencies across quality control, manufacturing, and laboratory operations. Key issues include inadequate investigations into sterility failures and out-of-specification results, untimely completion of annual product reviews, and failures in laboratory control mechanisms and instrument calibration. The firm also lacked proper stability testing programs, environmental monitoring in aseptic areas, and timely submission of Field Alert Reports for distributed drug products with significant changes.