FDA 483 - PT. TEAM-METAL INDONESIA - August 08, 2018

An FDA inspection of PT. TEAM-METAL INDONESIA, a medical device manufacturer in Batam, Indonesia, revealed a significant issue with process validation. The firm failed to adequately validate machining processes for critical medical device components, relying on sampling rather than full verification. This indicates a serious lapse in quality system procedures related to ensuring product quality and safety.