FDA 483 - Tianjin Bolang Science-Technology Development Co., Ltd. - March 30, 2021

Tianjin Bolang Science-Technology Development Co., Ltd., a medical device manufacturer in Tianjin, P.R. China, was cited for numerous fundamental quality system deficiencies during an FDA inspection. The firm lacked established procedures for critical areas such as complaint handling, medical device reporting, design control, device master records, corrective and preventive actions, and device history records. Additionally, the quality system record was inadequate, and personnel lacked knowledge of USFDA regulations, indicating a severe lack of compliance for devices intended for the US market.