FDA EIR - Cordis US Corp - March 31, 2016

The Level II risk-based inspection of Cordis Corporation's Miami Lakes facility, conducted from March 24 to March 31, 2016, focused on its role as a medical device component manufacturer, complaint handling facility, and sterilization record reviewer for Class II and III cardiovascular and endovascular devices. It assessed compliance with the Quality System (QS) regulations and Medical Device Reporting (MDR) requirements, specifically reviewing Management Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. The regulatory framework for this inspection was Compliance Program 7382.845, Inspection of Medical Device Manufacturers. Although no formal FDA-483 "Inspectional Observations" were issued, the inspection concluded with verbal observations. These centered on failures to maintain accurate eMDR communications for adverse event reports, inconsistencies in investigation documentation, and a lack of relevant information in some complaint investigations. Previous inspection observations had been appropriately corrected. Cordis Corporation management acknowledged the verbal observations, affirming their commitment to comply with FDA regulations and promising prompt corrective actions. The FDA investigator underscored management's responsibility to thoroughly investigate and address the root causes of these issues with permanent corrective actions, particularly regarding organizational structure, quality audits, management reviews, quality policy implementation, and training. The potential for further agency enforcement actions was also conveyed.