FDA 483 - MedicalSystem Biotechnology Co., Ltd. - March 14, 2019

An FDA inspection of MedicalSystem Biotechnology Co., Ltd., a medical device manufacturer in Ningbo, China, identified deficiencies in its complaint handling system. The firm's Customer Feedback Control Procedure was found to be incomplete, failing to ensure uniform and timely processing of complaints, proper documentation of oral complaints, and adequate evaluation for Medical Device Reporting. This indicates a significant issue with the firm's quality system regarding post-market surveillance and complaint management.