FDA 483 - Global Medical Technology SL - October 10, 2019

An FDA inspection of Global Medical Technology SL, a medical device manufacturer in San Sebastian de los Reyes, Madrid, Spain, revealed significant deficiencies across its quality system. The firm failed to establish fundamental procedures for design control, complaint handling, medical device reporting, and various other critical quality system elements. These widespread issues indicate a severe lack of control over the manufacturing and quality assurance processes for their Platinum GMT IPL system.