China NMPA Inspection - Zigong Hongda Medical Equipment Co., Ltd. - January 10, 2018

An unannounced inspection of Zigong Hongda Medical Device Co., Ltd. was conducted from November 20-21, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection identified six defects, four critical and two general, revealing significant gaps in the company's quality management system. Critical issues included failures by quality management personnel to implement inspection and record systems for product quality files and warehousing acceptance. Additionally, key quality management staff were not present, and their employment proof was unavailable. The company's computer system also lacked essential product purchase records. Substantial inconsistencies were found between the components and specifications of in-stock medical devices, such as Automatic Continuous Positive Airway Pressure (ACPAP) devices, breathing masks, patient monitors, and pulse oximeter sensors, and their official registration certificates. General findings included incomplete delivery documentation for various products, missing crucial details like manufacturer license numbers or batch numbers, and damaged packaging on disposable medical sheets and oxygen masks in the warehouse. In response, the Sichuan Provincial Food and Drug Administration is required to order Zigong Hongda Medical Device Co., Ltd. to rectify these deficiencies within a specified period, conduct follow-up inspections, and report the rectification status to the Medical Device Supervision Department of the State Administration for Market Regulation.