China NMPA Inspection - Changsha Jingtong Medical Equipment Co., Ltd. - January 10, 2018

An unannounced inspection of Sichuan Jinghong Medical Device Co., Ltd. and its third-party logistics provider, Sichuan Jinghong Pharmaceutical and Medical Device Third-Party Warehousing and Logistics Co., Ltd., was conducted on November 22-23, 2017. Based on the Good Manufacturing Practice for Medical Devices, the inspection revealed significant deficiencies in their quality management systems.

Sichuan Jinghong Medical Device Co., Ltd. received four citations, including three critical findings. Issues included quality management personnel failing to audit third-party logistics and review product qualifications, a lack of purchase records for various medical devices, ineffective staff training on regulations and product knowledge, and an inadequate computer system for managing medical device purchasing and sales qualifications.

The third-party logistics company incurred five citations, two critical. Violations encompassed inaccurate product acceptance records, discrepancies between packing lists and actual inventory, improper storage of medical devices directly on the ground without moisture protection, and a lack of regular verification for cold storage facilities. Additionally, their information system lacked full product traceability, and cold storage temperature records were incomplete.

As a result, the Sichuan Provincial Food and Drug Administration is required to mandate both companies to rectify these issues within a specified timeframe, conduct follow-up inspections, and report the compliance status to the State Administration for Market Regulation.