# China NMPA Inspection - Beijing Yuhengjia Technology Co., Ltd. - June 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/beijing-yuhengjia-technology-co-ltd/224eaf6b-45ef-49f6-8df9-9c9cfe20d850/
Source feed: China

> China NMPA unannounced inspection for Beijing Yuhengjia Technology Co., Ltd. published June 28, 2018. An unannounced inspection of Beijing Yuhengjia Technology Co., Ltd., a manufacturer of Aortic Covered Stents, was conducted on June 4, 2018. The inspe

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Beijing Yuhengjia Technology Co., Ltd.
- Company Name: Beijing Yuhengjia Technology Co., Ltd.
- Publication Date: 2018-06-28
- Product Type: Device
- Summary: An unannounced inspection of Beijing Yuhengjia Technology Co., Ltd., a manufacturer of Aortic Covered Stents, was conducted on June 4, 2018. The inspection was based on the Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices. During the inspection, it was verified that the company had ceased all production activities and was undergoing significant renovations to its cleanroom, sterilization room, and testing laboratory. These upgrades were part of a cleanroom installation project initiated in April 2018, with production officially halted and reported to authorities on June 1, 2018. The inspection did not identify defects related to active production, but rather confirmed the company's operational status. As a required action, Beijing Yuhengjia Technology Co., Ltd. must submit a written report to the Beijing Municipal Food and Drug Administration before resuming any production. Production can only recommence after the Municipal Administration conducts a follow-up inspection and confirms all requirements are met. The Municipal Administration is then responsible for informing the National Medical Products Administration upon the company's approved resumption of production.

Company: https://www.globalkeysolutions.net/companies/beijing-yuhengjia-technology-co-ltd/02db9516-580d-4b51-9ff0-890387063690/