NMPA Unannounced Inspection Notice: Jilin Wohong Medical Device Manufacturing Co., Ltd. Found with Serious Quality Management System Deficiencies

On September 21, 2026, the National Medical Products Administration issued Notice No. 33 of 2026, announcing that it had organized an inspection team to conduct an unannounced inspection of Jilin Wohong Medical Device Manufacturing Co., Ltd. and found serious deficiencies in the company's quality management system. The inspection identified the following issues: incomplete or unexecuted job responsibilities and qualification requirements for the company's management representative and quality assurance department head; incomplete work instructions that fail to effectively guide actual production; missing production records for certain products that do not meet traceability requirements; and inadequate product release review, with some batches lacking original testing records for ethylene oxide residue. These circumstances do not comply with the requirements of China's Good Manufacturing Practice for Medical Devices regarding organization and personnel, production management, and quality control.

The company has confirmed the above issues and suspended production. The provincial drug regulatory authority should continue to strengthen oversight, strictly handle any suspected violations of the Medical Device Supervision and Administration Regulation and related provisions in accordance with the law, and conduct supervisory sampling when necessary. The company has been ordered to assess product safety risks and implement corresponding risk control measures; products that may pose safety hazards shall be recalled in accordance with the Medical Device Recall Management Measures. Production may only resume after the company completes rectification and passes re-inspection.

As an unannounced inspection method, flight inspection is a critical tool for drug regulatory authorities to uncover genuine production issues. This notice serves as a reminder to all medical device manufacturers: an effective quality management system is not a paperwork exercise — it is a bottom line that concerns product safety and patient health.