FDA EIR - Nephron Pharmaceuticals Corp. - January 20, 2017

The FDA conducted a Good Manufacturing Practice (GMP) and Pre-Approval inspection of Nephron Pharmaceuticals Corporation's West Columbia, SC facility from January 9-20, 2017. The inspection, carried out under Compliance Programs 7356.002A and 7346.832, identified a significant violation documented on Form FDA 483, referencing 21 CFR 211.192. This observation highlighted that the company's investigations into out-of-specification results for Albuterol Sulfate Inhalation Solution 0.5% (lots Z5023A and Z4053A), specifically increasing levels of an unknown impurity, were inadequate as they did not extend to other potentially affected batches. Furthermore, timely follow-up Field Alert Reports (FARs) were not submitted, with one being provided only during the inspection. Verbally, management was also cited for failing to submit a FAR within the required three-day window for a complaint regarding a discolored sterile product vial containing foreign matter. In response, Nephron Pharmaceuticals committed to providing a formal written response to the FDA 483 within 15 business days. The company also presented draft revisions to several procedures and forms during the inspection to address numerous verbal observations, demonstrating a commitment to improving various aspects of their quality system, including media fill report content, preventive maintenance for Blow-Fill-Seal machine seal integrity, anaerobic environmental monitoring, cleanroom differential pressure testing, documentation of vial orientation, traceability of laboratory standards, QA inspector training records, retain sample examination procedures, personnel monitoring documentation, and the timely submission of Field Alert Reports.