China NMPA Inspection - Yunnan Haodi Medical Instrument Co., Ltd. - July 14, 2017

The State Food and Drug Administration (SFDA) conducted a surprise inspection of Yunnan Haodi Medical Device Co., Ltd., with findings announced on July 14, 2017. The inspection revealed serious deficiencies across the company's quality management system, indicating non-compliance with the "Good Manufacturing Practice for Medical Devices" and other relevant regulations.

Key violations included an understaffed quality department and significant issues with plant and facilities, such as faulty pressure gauges, inadequate cleanroom environment controls (temperature, humidity, drainage), and non-sterile washing procedures for cleanroom attire. Document management was found lacking, with unstamped controlled documents and incorrect recorded data for quality tests.

Furthermore, the company's design and development procedures were deficient, failing to address design conversion, risk management, and proper documentation/verification of process changes. Procurement processes were inconsistent, lacking essential plans, forms, and biological evaluation criteria for raw materials. Production management suffered from inconsistent records and unclear batch definitions, while quality control lacked original data retention for crucial tests. Nonconforming product control procedures were also found incomplete.

As a result, Yunnan Haodi Medical Device Co., Ltd. has been ordered to immediately cease production for rectification. They must assess product safety risks, recall any potentially hazardous products, and can only resume operations after completing all corrective actions and passing a subsequent inspection by the provincial food and drug administration.