FDA 483 - Aptar Stelmi SA - May 10, 2016

An FDA inspection conducted on May 9-10, 2016, at an unnamed firm revealed significant deficiencies in its quality system. The primary issue identified was a failure to thoroughly investigate unexplained discrepancies and instances where products or components did not meet specifications, even if already distributed. Specifically, the firm conducted incomplete investigations for non-conforming reports 15G76 and 15G127, which involved metal particulates. These investigations lacked crucial production analysis to determine the root cause or probable root cause of the contamination, despite reprocessing the affected component lots. Furthermore, an out-of-specification bioburden analysis found on January 20, 2015, for a critical sampling point also lacked a comprehensive production investigation, including an assessment of the root cause or potential quality impact on components processed that day. These observations indicate a departure from manufacturing quality standards, specifically regarding proper incident investigation and corrective action procedures, as outlined under the Federal Food, Drug, and Cosmetic Act. The firm is expected to address these observations by conducting thorough investigations, identifying root causes, implementing effective corrective actions, and ensuring compliance with regulatory requirements to prevent recurrence and maintain product quality and safety.