FDA 483 - Shanghai Kindly Enterprise Development Group Co., Ltd - July 19, 2011

Shanghai Kindly Enterprise Development Group Co., Ltd. in Shanghai, China, a medical device manufacturer, was inspected by the FDA from July 18-19, 2011. The inspection revealed issues with design verification documentation, inadequate equipment calibration schedules, and improper document approval procedures. These observations indicate deficiencies in the firm's quality system for medical device manufacturing.