LivaNova USA Inc. – FDA EIR, Sep 1, 2015

An FDA Level III For Cause, Directed inspection of Sorin Group USA, Inc. in Arvada, CO, was conducted from August 24 to September 1, 2015. The inspection, which focused on the Stockert Heater Cooler System 3T, a medical device manufactured by Sorin Group Deutschland (SGD), did not result in an FDA 483. However, the inspection, conducted under Compliance Program 7382.845 for Medical Device Manufacturers, identified several critical procedural gaps and issues that were discussed with management.

Key concerns highlighted deficiencies in the firm's Medical Device Reporting (MDR) system. Specifically, there was a lack of established mechanisms between Sorin Group USA and its sister facilities, like SGD, for filing supplemental MDRs and for comprehensively trending complaint and service data. This meant SGU frequently failed to submit required supplemental reports to the FDA and did not consistently forward all relevant service information to the device manufacturers for analysis.

Additionally, Sorin Group USA had not issued Supplier Quality Notifications to SGD regarding issues with the 3T device, indicating a failure to address potential quality problems effectively through its CAPA (Corrective and Preventive Action) system. The CAPA system itself showed weaknesses, with timeframes often exceeded without proper extensions and environmental monitoring CAPAs not being adequately trended for recurring issues. While no direct regulatory actions were mandated, management acknowledged the need to improve inter-facility communication and data sharing to ensure compliance with applicable medical device regulations.