FDA 483 - Jingzhou Haixin Green Cross Medical Products Co. Ltd. - April 15, 2019

Jingzhou Haixin Green Cross Medical Product Co., Ltd. in Songzi City, China, a Class II medical device manufacturer, was cited with four observations during an FDA inspection. The observations primarily concern deficiencies in design input documentation, adherence to document control procedures, proper complaint handling, and product identification throughout manufacturing stages. These issues indicate a lack of robust quality system controls.