FDA 483 - Shanghai ISO Medical Products Co., Ltd. - November 16, 2023

An FDA inspection of Shanghai ISO Medical Products Co., Ltd. in Shanghai, China, a medical device manufacturer, identified two observations. The firm was cited for failing to ensure medical device labels bear a Unique Device Identifier (UDI) as required. Additionally, the device history records did not adequately demonstrate that devices were manufactured according to the device master record, specifically regarding the packaging process.