Shanghai ISO Medical Products Co., Ltd.November 16, 2023

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

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Record Details

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.

Company: Shanghai ISO Medical Products Co., Ltd.
Inspection Date: November 16, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Thai T. Duong

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