FDA 483 - GAELTEC DEVICES LTD - December 07, 2017

An FDA inspection of GASTEC DEVICES LTD, a medical device manufacturer in Dunvegan, United Kingdom, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to process validation, corrective and preventive actions, complaint handling, equipment maintenance, and device history records. These findings indicate a lack of robust controls necessary for ensuring product quality and regulatory compliance.