China NMPA Inspection - Wuhu Daorun Pharmaceutical Co., Ltd. - December 13, 2018

Wuhu Daorun Pharmaceutical Co., Ltd. underwent an unannounced compliance inspection from November 6-7, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed multiple deficiencies across various aspects of their operations. Key issues included inadequate facility and equipment maintenance, such as a loose washing machine drain pipe, corroded conveyor surfaces, rusty benches, and unzeroed pressure gauges. Environmental control was found lacking, with intermittent air conditioning system use not followed by required monitoring for restarts, and absent cleaning records for raw material sampling vehicles. Cleaning protocols were also deficient, evidenced by residual powder in a dispensing machine and missing records for disinfectant preparation. Significant documentation and record-keeping problems were identified. These included inaccurate raw material labeling, illegible material requisition records, and incomplete production batch records lacking details on self-cleaning processes, equipment numbers, process parameters, and instrument calibration identifiers. A critical discrepancy was noted between established hardening time ranges and actual recorded production parameters for ultrasonic welding. Furthermore, the company failed to adhere to its own quality control procedures, with inconsistent finished product sample retention, no records of required annual customer follow-ups, and missing quality management system training records for some personnel. As a result, the company is mandated to rectify these issues within a specified timeframe, assess product safety risks, and initiate product recalls if safety hazards are identified. The provincial drug administration is required to conduct follow-up inspections and report on the company's rectification efforts to the National Medical Products Administration.