FDA 483 - Nephron Sterile Compounding Center LLC - July 06, 2016

An FDA inspection of NEPHRON PHARMACEUTICALS CORPORATION in West Columbia, SC, a sterile drug manufacturer, identified five significant deficiencies. These included inadequate laboratory record-keeping, insufficient employee training, and failures in documenting test method accuracy and process control deviations. The findings indicate a moderate level of non-compliance with good manufacturing practices, particularly concerning quality control and data integrity.