FDA 483 - Mauna Kea Technologies - May 17, 2018

An FDA inspection of Mauna Kea Technologies in Paris, France, a medical device manufacturer, revealed significant deficiencies in their complaint handling procedures. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, leading to issues with uniform processing, documentation of oral complaints, and investigation of device failures. This indicates a moderate level of non-compliance with quality system requirements.