FDA 483 - IDS LTD - April 25, 2019

An FDA inspection of IDS LTD, a medical device manufacturer in Seoul, Korea, revealed a significant issue with their device history records. The firm failed to demonstrate that devices were manufactured in accordance with 21 CFR 820. Specifically, device history records lacked or did not refer to the location of primary identification labels, labeling, and unique device identifiers (UDI) for each production unit.