FDA 483 - LivaNova USA Inc. - September 01, 2015

An FDA directed inspection of Sorin Group USA, Inc. (Arvada, CO) was conducted from August 24 to September 1, 2015, under Compliance Program 7382.845 (Inspection of Medical Device Manufacturers). The inspection, focused on the Stockert Heater Cooler 3T device, aimed to assess the company’s Medical Device Reporting (MDR) and Corrective and Preventive Action (CAPA) systems.

While no FDA Form 483 was issued, the inspection identified critical operational gaps. These included a lack of documented procedures for Sorin Group USA to obtain supplemental MDR information from Sorin Group Deutschland, leading to potential delays in regulatory filings. There was also an absence of a formal mechanism for Sorin Group USA to share complaint trending data and service information with sister manufacturing facilities, hindering global quality system analysis. Furthermore, Sorin Group USA had not issued Supplier Quality Notifications to its German counterpart regarding identified issues with the 3T device. The CAPA system exhibited weaknesses, with timelines frequently exceeded without justification and an inadequate trending process that failed to identify recurring issues, such as environmental monitoring problems. Management acknowledged these deficiencies, recognizing the need to implement continuous quality improvements, particularly by enhancing inter-company information exchange and feedback mechanisms to ensure ongoing regulatory compliance.