Nephron Pharmaceuticals Corp. – FDA 483, May 18, 2010

An FDA inspection of Nephron Pharmaceuticals Corp. in Orlando, FL, a drug product manufacturer, revealed significant issues across three observations. The firm's quality control unit lacked proper oversight for approving procedures and specifications impacting drug product quality, particularly concerning microbiology lab results. Additionally, drug product containers were not stored to prevent contamination, and the facility's clean rooms were not maintained in good repair, showing rust and a lack of monitoring for such conditions.