FDA 483 - Fidia Farmaceutici S.p.A. - November 10, 2016

An FDA inspection of Fidia Farmaceutici S.p.A. in Abano Terme, Italy, a medical device manufacturer, revealed a significant repeat observation regarding inadequate statistical techniques. The firm failed to adequately establish procedures for identifying valid statistical techniques for process capability and product characteristics, specifically concerning the sampling of rubber stoppers and glass syringes. This indicates a serious lapse in quality control processes.