Thoratec LLC – FDA EIR, Jun 12, 2017

An FDA inspection of Thoratec Corporation in Pleasanton, CA, was conducted from June 5 to June 12, 2017. This was a Premarket Approval (PMA) inspection for their HeartMate III Left Ventricular Assist System (LVAS), adhering to various compliance programs, including those for Medical Device Reporting (MDR) and Unique Device Identification (UDI). The inspection confirmed that all observations from a previous 2015 inspection, which had cited issues with design validation, risk analysis, and statistical techniques, had been effectively corrected. Notably, no FDA-483 inspectional observations were issued during this 2017 inspection. A key discussion point with management revolved around the late filing of Medical Device Reports. Thoratec demonstrated proactive measures, including initiating a Corrective and Preventive Action (CAPA), increasing staff, and enhancing training, which showed a significant reduction in late reporting. Additionally, a State of California representative noted that the firm had not updated its state registration to reflect a change in ownership. While no formal FDA required actions stemmed from this inspection, the firm was actively addressing the MDR reporting issue, and the state registration update would be a separate requirement.