FDA 483 - LivaNova Deutschland GmbH - April 28, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
LivaNova Deutschland GmbH, a medical device manufacturer in Munich, Germany, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish design validation procedures for its Heater-Cooler System 3T, including insufficient testing of updated Instructions for Use following recalls. Additionally, the disinfection process for the device was not adequately validated, and complaints involving device failures were not investigated as required.
ID · ea77f1fe-c32d-4bd6-ac1b-757cd4d2020b