China NMPA Inspection - Yangzhou Xiaokang Medical Equipment Co., Ltd. - November 04, 2025

An unannounced inspection by the National Medical Products Administration (NMPA), documented on November 3, 2025, revealed critical quality management system deficiencies across four medical device manufacturers, violating the "Good Manufacturing Practice for Medical Devices" and "Regulations on the Supervision and Administration of Medical Devices."

The first company exhibited systemic traceability failures in production records, quality control (sterility, raw material, process inspections), sales records, and adverse event monitoring. Jiangxi Jinsheng Medical Device Group Co., Ltd. had inconsistencies in design and development (raw material specifications, biological evaluations), extensive quality control issues (incomplete inspection reports, inconsistent procedures, lack of sampling records), inadequate non-conforming product management, and failed to act on frequent adverse events.

Tibet Beizhuya Pharmaceutical (Group) Co., Ltd. showed critical gaps in design control for material changes, deficient procurement processes with unclear quality standards, poorly defined production parameters, and insufficient analysis of non-conforming products. Qinghai Ruilang Medical Technology Development Co., Ltd. lacked dedicated inspection personnel, operated with compromised facilities (shared air purification, no environmental monitoring), demonstrated procurement and production record traceability failures, and critically omitted essential finished product tests like ethylene oxide residue and sterility.

All companies acknowledged the issues. Regulatory authorities are mandated to order immediate production suspension, conduct supervisory sampling, pursue legal action for violations, require product safety risk assessments, and recall hazardous products. Production can only resume after comprehensive rectification and a successful re-inspection by provincial drug regulatory authorities.