FDA 483 - Nephron Pharmaceuticals Corp. - February 21, 2014

Nephron Pharmaceuticals Corp. in Orlando, FL, a sterile drug and device manufacturer, was cited for numerous significant deficiencies across its quality system, laboratory controls, and medical device procedures. Key issues include inadequate investigations into out-of-specification drug products, failure to submit field alert reports, and widespread lack of established or followed procedures for stability testing, labeling control, and corrective/preventive actions. The firm also failed to adequately manage and report adverse drug and device events, including a Class I recall for a choking hazard.