FDA EIR - Stradis Healthcare - March 22, 2018

An FDA inspection of Stradis Healthcare, located in Waukegan, IL, was conducted from March 20-22, 2018. This risk-based inspection, requested by the Center for Device and Radiological Health (CDRH), followed the FY18 Risk-Based Work Plan and focused on compliance with quality system regulations for medical devices, particularly IV administration sets (Class II). The scope included management, design, corrective and preventive actions (CAPA), and production and process controls. While the inspection did not result in a formal FDA 483 form with observations, several critical areas requiring attention were identified during discussions with management. Key issues included the CAPA procedure lacking a requirement for analyzing quality data, the absence of documented dates for evaluating complaints for Medical Device Report (MDR) reportability, and inadequate implementation of Unique Device Identifier (UDI) for Class II devices, where the compliance deadline had passed. Furthermore, the firm's Risk Analysis procedure was deemed insufficient as it had not been updated for IV start kits since their 510(k) clearance in 1995, failing to incorporate new post-market information. Stradis Healthcare’s management expressed cooperation and committed to addressing these discussed items to ensure full regulatory adherence.