# China NMPA Inspection - Jiangxi Hongxin Medical Device Group Co., Ltd. - June 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-hongxin-medical-device-group-co-ltd/10a8bfff-e6dd-41b0-a3db-72d5e0a72142/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Hongxin Medical Device Group Co., Ltd. published June 23, 2017. An unannounced inspection conducted by the State Food and Drug Administration (NMPA) on May 11-12, 2017, identified serious deficiencies at Jiangxi Ho

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio and Television on Urging Jiangxi Hongxin Medical Device Group Co., Ltd. to Suspend Production and Rectify Issues Discovered During the Surprise Inspection
- Company Name: Jiangxi Hongxin Medical Device Group Co., Ltd.
- Publication Date: 2017-06-23
- Product Type: Device
- Summary: An unannounced inspection conducted by the State Food and Drug Administration (NMPA) on May 11-12, 2017, identified serious deficiencies at Jiangxi Hongxin Medical Device Group Co., Ltd. The inspection, carried out under the "Measures for Unannounced Inspections of Drugs and Medical Devices" and referencing "Good Manufacturing Practice for Medical Devices," revealed critical issues within the company's production quality management system. The primary violations centered on a fundamental lack of product traceability. Records for raw materials, such as PVC tubing, polyethylene, and ABS, could not be consistently linked to actual batch numbers on-site. Significant discrepancies were found between documented inventory and physical stock, with materials present in the warehouse lacking corresponding inspection or usage records, and vice versa. Furthermore, 16 boxes of semi-finished disposable infusion sets were discovered in a sterilizer with untraceable origins, contradicting production records. As a result, Jiangxi Hongxin Medical Device Group Co., Ltd. has been ordered to immediately cease production for comprehensive rectification, in accordance with the "Regulations on the Supervision and Administration of Medical Devices." The company must resolve all identified deficiencies and pass a follow-up inspection before resuming operations. The provincial food and drug administration is required to publish details of the suspension and rectification online, enhance daily oversight, and ensure strict adherence to manufacturing practices to guarantee medical device safety and effectiveness.

Company: https://www.globalkeysolutions.net/companies/jiangxi-hongxin-medical-device-group-co-ltd/32c6abd6-3690-4c46-a4d1-99b1f56de530/