# China NMPA Inspection - Zhengzhou Dior Medical Technology Co., Ltd. - October 11, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/zhengzhou-dior-medical-technology-co-ltd/fe7a7592-7c9c-4283-880e-25f922bc99cd/
Source feed: China

> China NMPA unannounced inspection for Zhengzhou Dior Medical Technology Co., Ltd. published October 11, 2018. An unannounced inspection of Zhengzhou Dior Medical Technology Co., Ltd., producer of Disposable Peripherally Inserted Central Catheter Kits, was cond

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Zhengzhou Dior Medical Technology Co., Ltd.
- Company Name: Zhengzhou Dior Medical Technology Co., Ltd.
- Publication Date: 2018-10-11
- Product Type: Device
- Summary: An unannounced inspection of Zhengzhou Dior Medical Technology Co., Ltd., producer of Disposable Peripherally Inserted Central Catheter Kits, was conducted from September 6th to September 8th, 2018. The inspection assessed compliance with *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*.Serious violations included critical failures in ethylene oxide residue testing, with instances of incomplete or incorrectly prepared standard curves, and untraceable or mismatched test data for sterilized products. Significant breaches of cleanroom integrity were also identified, such as open windows and unsealed pipe holes directly connecting to the outside, and deformed doors in Class 100,000 clean areas.Numerous general deficiencies were found, including ineffective ventilation in the finished product warehouse, lack of usage records for some production equipment, uncalibrated measuring instruments, and inadequate document control (e.g., unmarked obsolete documents, altered records). Worker safety was compromised by the absence of protective measures in areas with toxic gases. Additionally, there were widespread cleanroom environmental control issues, such as compromised structural integrity, uncontrolled pressure differences, insufficient humidity, lack of environmental monitoring in critical areas, water leaks, and mold. Improper storage of raw and auxiliary materials was also noted.Consequently, Zhengzhou Dior Medical Technology Co., Ltd. has been ordered to immediately suspend production for comprehensive rectification. The company must analyze root causes, assess product safety risks, recall any potentially hazardous products, and implement all necessary corrective measures. Production resumption is contingent upon successful completion of rectification and a follow-up inspection by the Provincial Administration, with regulatory actions and company progress to be publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/zhengzhou-dior-medical-technology-co-ltd/770d4d57-bfec-4699-81eb-afa1eb53ed8f/