FDA 483 - Tianjin Medis Medical Device Co., LTD.

An FDA inspection of Tianjin Medis Medical Device Co., Ltd. in Tianjin, China, revealed two significant observations. The firm failed to adequately document effectiveness checks for several Corrective and Preventive Actions (CAPAs). Additionally, the Design History File for their AccuCuff device lacked essential documentation regarding labels, labeling, and product testing for devices marketed in the United States.