China NMPA Inspection - Zhejiang Kehui Medical Instrument Co., Ltd. - June 23, 2017

An unannounced inspection by the State Food and Drug Administration (SFDA) in early 2017 identified serious deficiencies at Zhejiang Sujia Medical Device Co., Ltd. The findings, announced on June 23, 2017, indicated widespread non-compliance with the "Good Manufacturing Practice for Medical Devices" and national mandatory standards.

Significant violations encompassed several areas. Plant and facilities exhibited issues with cleanroom renovation, differential pressure control, and environmental contamination. Equipment management was flawed, including improper handling of water for injection and inadequate re-verification of cleanroom air systems after shutdowns. Document management showed unauthorized alterations to records. Design and development processes lacked appropriate change control and risk assessments for material modifications. Procurement practices were substandard, with inadequate supplier evaluations, incomplete quality agreements, and missing biological evaluation records for critical components. Production management failed to meet aging test requirements, and quality control procedures were deficient, lacking comprehensive testing and proper sample retention. Additionally, sales records were incomplete, and there was no robust control system for non-conforming products or rework.

Consequently, Zhejiang Sujia Medical Device Co., Ltd. has been mandated to immediately cease production and undertake comprehensive rectification. The company must assess product safety risks and recall any potentially hazardous products as per the "Measures for the Recall of Medical Devices." Production may only resume after all corrective actions are completed and a satisfactory follow-up inspection is passed.