FDA 483 - LivaNova Deutschland GmbH - August 27, 2015

The FDA inspected Sorin Group Deutschland GmbH in Munchen, Germany, a medical device manufacturer, from August 24-27, 2015. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the inadequate validation of disinfection processes for their Heater-Cooler System 3T, which had been linked to Mycobacterium chimaera contamination. Additionally, the firm lacked adequately established procedures for validating new manufacturing processes.