FDA 483 - Dongguan Kepler Special Cabling Company Limited - April 19, 2019

An FDA inspection of Dongguan Kepler Special Cabling Company Limited, a medical device manufacturer in Dongguan, China, revealed seven observations related to its quality system for contract manufactured Disposable ECG Cables. Deficiencies included inadequate process validation, uncontrolled production processes, and a lack of established procedures for finished device and in-process acceptance. The firm also failed to properly identify product acceptance status, adequately document acceptance activities, and ensure executive management review of the quality system.