# 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/2b5c7990-5000-4d5f-a1a5-eaf48a5bd99f/
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> China NMPA unannounced inspection for Jiangxi Hongxin Medical Device Group Co., Ltd. published June 23, 2017. An unannounced inspection by the State Food and Drug Administration (SFDA), announced on June 23, 2017, revealed serious deficiencies at Jiangxi Hongx

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## Details

- Record Type: CHINA_INSPECTION
- Title: State Administration of Radio, Film and Television Announcement No. 94 of 2017 Regarding the Suspension of Production and Rectification of Jiangxi Hongxin Medical Device Group Co., Ltd.
- Company Name: Jiangxi Hongxin Medical Device Group Co., Ltd.
- Publication Date: 2017-06-23
- Product Type: devices
- Summary: An unannounced inspection by the State Food and Drug Administration (SFDA), announced on June 23, 2017, revealed serious deficiencies at Jiangxi Hongxin Medical Device Group Co., Ltd. The company was found to be in non-compliance with the *Good Manufacturing Practice for Medical Devices* (GMP) and related regulatory frameworks.

Key violations included severe understaffing in quality management, uncalibrated or damaged facility monitoring equipment, and inadequate cleanroom controls. Critical equipment, such as particle counters, had expired calibration certificates, and the purified water system validation was incomplete, showing rust-colored water. Document management was poor, with uncontrolled paper and electronic records. Furthermore, the inspection identified significant issues in design and development, where product property and process changes lacked proper records and risk assessments. Production management suffered from incomplete batch records, missing traceability information, and inadequate identification of product status for both qualified and unqualified items. Quality control failed to maintain raw material inspection and usage records, leading to untraceable products.

As a result, Jiangxi Hongxin Medical Device Group Co., Ltd. has been ordered to immediately cease production and rectify all identified issues. The company faces severe punishment for violating the *Regulations on the Supervision and Administration of Medical Devices*, must assess product safety risks, and recall any potentially unsafe products. Production can only resume after all corrective actions are completed and verified through a follow-up inspection.

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