FDA 483 - Jiangsu Xinbei Electrical Appliance Co., LTD. - November 09, 2023

An FDA inspection of Jiangsu Xinbei Electrical Appliance Co., LTD. in Wuxi, China, a medical device manufacturer, was conducted from November 6-9, 2023, resulting in an FDA Form 483 with seven observations. The inspection revealed significant deficiencies in the company's quality management system, particularly concerning documentation and procedural adherence.

Key issues included inadequate procedures for receiving, reviewing, and evaluating customer complaints, with electronic handling software not integrated into formal documentation and complaint records lacking essential details. The company also failed to establish a timely and effective system for identifying and electronically submitting Medical Device Reports (MDRs), with insufficient information documented for reporting determinations. Corrective and preventive action (CAPA) procedures were found to be poorly defined, lacking accurate requirements for software use and comprehensive activity documentation.

Furthermore, procedures for controlling nonconforming products were inadequate, with improper identification and undocumented rework results and concession justifications. Critical design control issues were also noted, specifically the lack of complete documentation for design validation results and design review records in the Design History File. Finally, equipment calibration was found deficient, with an unidentifiable pressure gauge and unrecorded calibration status. The company committed to addressing and correcting all identified observations to ensure compliance with quality system regulations.