FDA 483 - Zoll Manufacturing Corp. - June 20, 2014

Zoll Lifecor Corporation, a medical device manufacturer in Pittsburgh, PA, was cited for severe deficiencies in its quality system, particularly regarding Medical Device Reporting (MDRs) and complaint handling. The inspection revealed failures to report serious injuries and malfunctions, inadequate investigations, and a lack of documented corrective actions for devices delivering inappropriate shocks. These issues indicate a systemic breakdown in ensuring device safety and regulatory compliance.