FDA EIR - LivaNova USA Inc. - March 26, 2013

An FDA Level II surveillance inspection of Sorin Group USA, Inc., located in Arvada, CO, was conducted from March 19 to March 26, 2013, under Compliance Program 7382.845 for medical device manufacturers. The inspection utilized the Quality System Inspection Technique (QSIT), covering Management Control, Design Control, Corrective and Preventive Actions (CAPA), and Production and Process Control subsystems. The company manufactures and distributes medical devices such as perfusion tubing systems and endoscopic vessel harvesting kits. The inspection identified two primary Quality System regulation deficiencies, documented on an FDA-483, Inspectional Observations form. Firstly, the firm failed to validate design under defined operational conditions. Secondly, design verification did not consistently confirm that design output met input requirements. Management, represented by the Director of Quality Assurance, acknowledged these observations and committed to correcting them, promising a written response within 15 business days. Further discussions highlighted the need for Sorin Group USA to review and revise procedures and forms for improved clarity and applicability, ensure validations include original raw data, and implement comprehensive follow-up and documentation for all complaints and CAPA investigations. The FDA also emphasized clarifying Medical Device Reporting and recall responsibilities, especially concerning products and components from their international sister facilities, and noted potential legal sanctions for non-compliance.