# China NMPA Inspection - Tianjin Zhixin Hongda Medical Device Development Co., Ltd. - October 30, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-zhixin-hongda-medical-device-development-co-ltd/b8791791-84b3-48da-a6a1-4cc43c921e8d/
Source feed: China

> China NMPA unannounced inspection for Tianjin Zhixin Hongda Medical Device Development Co., Ltd. published October 30, 2017. Tianjin Zhixin Hongda Medical Device Development Co., Ltd. underwent an unannounced inspection from September 25-27, 2017, based on Good Manufacturing

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Tianjin Zhixin Hongda Medical Device Development Co., Ltd.
- Company Name: Tianjin Zhixin Hongda Medical Device Development Co., Ltd.
- Publication Date: 2017-10-30
- Product Type: Device
- Summary: Tianjin Zhixin Hongda Medical Device Development Co., Ltd. underwent an unannounced inspection from September 25-27, 2017, based on Good Manufacturing Practice for Medical Devices. The inspection revealed 11 general deficiencies in its production of hemodialysis dry powder and concentrate. Key issues included inadequate cleanroom management, with cleaning supplies improperly stored and damaged facility components, and insufficient warehouse capacity leading to outdoor storage of raw materials and finished products. The company's documentation was found lacking, specifically in raw material inspection reports for sodium chloride, which omitted crucial testing details, and a failure to properly review design changes for product technical requirements, such as solute concentration and endotoxin limits for hemodialysis dry powder. Furthermore, supplier management was deficient as updated drug registration certificates for raw materials like sodium chloride and sodium bicarbonate were not timely obtained or included in supplier evaluations. Operational control issues included improper cleaning of packaging containers, incomplete production batch records lacking equipment serial numbers, and a lack of status markings for disinfected items. Quality control failures were identified, with particulate contamination test instruments not calibrated semi-annually as required, and a complete absence of microbial limit testing for several raw materials and packaging components. The company also failed to effectively analyze microorganism data for materials and intermediate products. As a result, the company is required to rectify all identified issues within a specified timeframe, assess product safety risks, recall any hazardous products, and report its corrective actions to the State Administration for Market Regulation, with follow-up inspections possible.

Company: https://www.globalkeysolutions.net/companies/tianjin-zhixin-hongda-medical-device-development-co-ltd/41ea49c3-92ee-49c9-bf35-388dd1891765/