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

A recent unannounced inspection by the State Food and Drug Administration uncovered significant deficiencies in the quality management system of Zhejiang Sujia Medical Device Co., Ltd. Guided by the "Good Manufacturing Practice for Medical Devices" and associated "Specifications," the inspection revealed multiple violations across several critical operational areas. Regarding plant and facilities, the company failed to adequately document and verify cleanroom renovations and stored components improperly. A finished product chute directly connected a cleanroom to a non-clean area, compromising sterility and resulting in insufficient differential pressure (1 Pa against the required >5 Pa). Additional issues included insect contamination in cleanroom lighting and incorrectly opening doors. Equipment-related findings included improper storage of water for injection (room temperature, stagnant sections) and a failure to verify cleanroom cleanliness following an extended shutdown of the air purification system. Document management issues were prominent, notably the unauthorized alteration of environmental monitoring records to show false compliance, lacking proper annotation. Design and development processes demonstrated a lack of adherence to regulations, with changes to manufacturing methods, supplier selections, and micro-motor specifications implemented without appropriate review, verification, or risk assessment. Finally, procurement concerns involved raw material inspection reports for PVC film missing mandatory testing items and critical Category A material suppliers being misclassified. The company is required to promptly address and rectify these extensive shortcomings to ensure full compliance with medical device manufacturing standards.