FDA WARNING_LETTER - Sorin Group Deutschland GmbH - September 01, 2015

The FDA issued a Warning Letter to LivaNova (formerly Sorin Group S.p.A.) following inspections of their Munchen, Germany, and Arvada, USA facilities in August-September 2015. The inspections revealed that their Stockert Heater Cooler 3T thermal regulator devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information.

Key violations at the Munchen facility include: 1. **Failure to establish and maintain procedures for design changes (21 CFR 820.30(i)):** Design Change Order #8115, intended to address prior deficiencies, had incomplete design input regarding water quality and inadequate design validation for cleaning Instructions for Use (IFU). Subsequent Design Change Orders (9416, 9416-01, 9711, 9690) related to a recall for updated cleaning IFUs also lacked adequate verification/validation, with issues in acceptance criteria, disinfectant equivalency, bacterial concentrations, water measurement accuracy, sampling methods, statistical rationale, and usability testing. This is a repeat violation from a 2011 Warning Letter. 2.