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

An FDA inspection of Shanghai ISO Medical Products Co., Ltd. was conducted from November 13 to November 16, 2023. This inspection, outlined in an FDA 483 report, identified two significant observations regarding the company's compliance as a medical device manufacturer. The first observation noted that labels for medical devices, specifically LIGHTSTONE MEDICAL Tzoar Negative Pressure Wound Therapy Foam Kits, lacked a Unique Device Identifier (UDI). This omission contravenes regulatory requirements outlined in 21 CFR 801 Subpart B and 21 CFR 830, which mandate UDIs on medical device labels. The second observation highlighted deficiencies in the device history records. The inspection found that manufacturing documentation did not adequately demonstrate that devices, including the aforementioned wound therapy kits, were produced in accordance with their respective device master records. Specifically, the packaging process was not properly documented in the device history records for certain lots. These observations indicate a need for improved adherence to quality system regulations concerning product labeling and manufacturing documentation. Shanghai ISO Medical Products Co., Ltd. acknowledged these findings and committed to implementing corrective actions for both observations. The firm is expected to address these issues to ensure full compliance with FDA regulations.