FDA 483 - LivaNova USA Inc. - March 26, 2013

Sorin Group USA, Inc. in Arvada, CO, was inspected from March 19-26, 2013, revealing significant deficiencies in their design control processes. The firm failed to validate the design of the EasyFlow Duo Cannula with Guidewire under defined operating conditions, lacking proper protocols and sample identification. Additionally, design verification documentation was inadequate, failing to confirm that design output met input requirements, with issues such as missing statistical rationale, raw data, and calibration information.