FDA EIR - LivaNova USA Inc. - July 14, 2009

The FDA conducted a targeted inspection of Sorin Group USA, Inc. in Arvada, CO, from July 2-14, 2009. This Level III inspection, guided by CDRH Assignment #090731 and CP 7382.845, focused on complaint handling, Medical Device Reporting (MDR), Corrective and Preventive Actions (CAPA), and production controls. The inspection was partly initiated by a CDC inquiry concerning two sepsis cases at a hospital where Sorin devices were in use. Notably, the inspection concluded with no objectionable conditions identified, and consequently, no Form FDA-483 (Inspectional Observations) was issued to the company. The previous inspection's observation regarding inconsistent complaint handling and MDR reporting was confirmed as corrected during this visit. While no regulatory actions were required, the FDA verbally advised the firm to improve documentation clarifying the rationale for not reporting certain malfunctions as MDRs. The company also has ongoing internal CAPAs to address product quality concerns related to component leaks and breaks.