China NMPA Inspection - Heilongjiang Xinpinxi Medical Technology Co., Ltd. - May 24, 2024

The National Medical Products Administration (NMPA) announced unannounced inspections of Heilongjiang Xinpinxi Medical Technology Co., Ltd. and Sanyuan Fusheng Medical Device Co., Ltd., publicized on May 24, 2024. These inspections revealed significant quality management system deficiencies, failing to comply with the *Good Manufacturing Practice for Medical Devices*.

Heilongjiang Xinpinxi Medical Technology Co., Ltd. was cited for issues including inconsistent ion testing methods and insufficient verification in design and development, a lack of process verification after equipment changes in production, and incomplete data for management reviews regarding adverse event monitoring.

Sanyuan Fusheng Medical Device Co., Ltd. faced multiple violations. Key issues included microbiology inspectors lacking practical testing assessments, unverified changes to facility infrastructure like a new control room and process water system, and risks in cleanroom exhaust systems. Production management failures involved discrepancies in material records and releasing products with non-conforming fill weights. Quality control was severely compromised by inconsistent testing methods, the use of outdated Pharmacopoeia editions without proper change control, and falsified inspection records where visible colonies were marked as "0" and non-conforming products were released.

Both companies acknowledged these deficiencies. Provincial drug regulatory authorities are mandated to order immediate production suspension, assess product safety risks, initiate recalls for hazardous products under the *Measures for the Administration of Medical Device Recalls*, and pursue legal actions for regulatory violations. Production resumption is contingent upon complete rectification and a successful re-inspection.