# China NMPA Inspection - Zhejiang Kehui Medical Instrument Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/zhejiang-kehui-medical-instrument-co-ltd/8a2617d7-c743-437f-83e7-1cf6a5c9951e/
Source feed: China

> China NMPA unannounced inspection for Zhejiang Kehui Medical Instrument Co., Ltd. published July 16, 2018. Zhejiang Kehui Medical Device Co., Ltd. was subject to an unannounced inspection between June 26-27, 2018, focusing on their Spinal Internal Fixation 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Zhejiang Kehui Medical Instrument Co., Ltd.
- Company Name: Zhejiang Kehui Medical Instrument Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: Zhejiang Kehui Medical Device Co., Ltd. was subject to an unannounced inspection between June 26-27, 2018, focusing on their Spinal Internal Fixation Device - Rod-Screw System. The inspection was based on the regulatory guidelines of *Good Manufacturing Practice for Medical Devices* and its *Appendix for Implantable Medical Devices*. The inspection revealed six general deficiencies impacting quality and safety protocols. Significant findings included the absence of temperature and humidity records for the finished product warehouse on non-working days, and an Infrastructure Control Procedure lacking a reconfirmation cycle for the shearing machine. Laboratory operating procedures for critical instruments were not available on-site, requiring digital access. Furthermore, ultrasonic cleaning records failed to specify the actual set temperature, and intermediate products in the inspection area lacked proper status labels. A cleanroom deficiency involved inadequate disinfectant levels for hand immersion and a validation plan that did not define container specifications or dosage. Consequently, Zhejiang Kehui Medical Device Co., Ltd. is mandated to rectify these issues promptly, assess all associated product safety risks, and initiate product recalls if any safety hazards are identified. The Zhejiang Provincial Food and Drug Administration will conduct follow-up inspections and report the rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/zhejiang-kehui-medical-instrument-co-ltd/8a10d64a-dd95-43a4-ae49-2597aa88b378/