NMPA Orders Production Suspension of Jilin Zhongchi Medical Technology for GMP Violations

On June 26, 2026, the National Medical Products Administration (NMPA) issued Announcement No. 22 of 2026, reporting the findings of an unannounced inspection (flight inspection) conducted on Jilin Zhongchi Medical Technology Co., Ltd.

The inspection revealed serious deficiencies in the company's quality management system, specifically including: the incoming inspection records for the key raw material, magnetron, lacked the original factory number information; the production work instructions omitted certain process steps; production records were incomplete and non‑traceable; and finished product inspection procedures had not been established in accordance with the product technical requirements. The above issues violate the requirements for procurement management, production management, and quality control as stipulated in the Medical Device Production Quality Management Standard.

The company has confirmed the identified deficiencies. The relevant provincial drug regulatory authority has ordered a suspension of production. The company is required to assess product safety risks and, in accordance with the Medical Device Recall Management Measures, recall products that may pose safety hazards. Production may only resume after all corrective actions have been completed and the provincial drug regulatory authority has confirmed compliance through a re‑inspection.

This enforcement action demonstrates the NMPA's continued commitment to strictly overseeing medical device manufacturers through its flight inspection program. The agency has been increasingly active in conducting unannounced inspections to verify whether companies comply with Good Manufacturing Practice (GMP) requirements, particularly for manufacturers of higher‑risk medical devices.

The deficiencies exposed in this case—incomplete raw material records, missing production steps, non‑traceable records, and inadequate inspection procedures—represent fundamental failures in quality management that could compromise product safety and efficacy. The NMPA's swift enforcement measures, including production suspension and mandatory recall, send a clear signal to the industry that GMP compliance is non‑negotiable.