# China NMPA Inspection - Jiangxi Hongda Medical Equipment Group Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-hongda-medical-equipment-group-co-ltd/85236d88-acbb-4b06-82e5-200a2da2ae97/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Hongda Medical Equipment Group Co., Ltd. published August 15, 2018. Jiangxi Hongda Medical Device Group Co., Ltd. underwent an unannounced compliance inspection by the NMPA on July 24-25, 2018, for its Disposable Preci

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Hongda Medical Device Group Co., Ltd.
- Company Name: Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: Jiangxi Hongda Medical Device Group Co., Ltd. underwent an unannounced compliance inspection by the NMPA on July 24-25, 2018, for its Disposable Precision Filter Infusion Set with Needle. The inspection, conducted under the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, identified nine general deficiencies.

Key issues included an invalid temperature and humidity meter in a raw material warehouse, an ineffective rodent barrier, and unclearly divided storage areas where non-conforming products were mixed with other items. The company failed to update inspection procedures following product registration changes. Critical equipment, such as a "Medical Needle Flow Meter," lacked calibration markings, and a differential pressure indicator in a Class 100,000 clean area was malfunctioning. Furthermore, a pulverizing room in the cleanroom lacked established environmental condition management, personnel brought personal belongings into the clean area, and comprehensive management documents for workstation equipment were absent.

Consequently, the Jiangxi Provincial Food and Drug Administration was directed to mandate rectification of all identified issues within a specified period. Jiangxi Hongda must assess product safety risks and, if necessary, recall hazardous products. The provincial authority is also required to conduct follow-up inspections and report the rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/jiangxi-hongda-medical-equipment-group-co-ltd/0e8bdf21-c0a6-4911-a1f7-1cb34727ac97/