FDA 483 - ZhongHong (DongGuan) Abrasives Co. Ltd. - July 26, 2019

Zhonghong (DongGuan) Abrasives Co. Ltd. in Dongguan, China, was inspected by the FDA on July 26, 2019, regarding its manufacturing of cautery tip cleaners. The inspection revealed two significant issues: inadequate maintenance of device history records and insufficient procedures for ensuring purchased products and services conform to requirements. These observations indicate deficiencies in the firm's quality system for medical device manufacturing.