# China NMPA Inspection - Guangxi Weili Ark Technology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-weili-ark-technology-co-ltd/90ab1255-8863-4d1e-9bf7-2cc982175ad1/
Source feed: China

> China NMPA unannounced inspection for Guangxi Weili Ark Technology Co., Ltd. published August 15, 2018. An unannounced inspection of Guangxi Weili Ark Technology Co., Ltd. was conducted on July 26, 2018, under the regulatory framework of Good Manufacturi

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Guangxi Weili Ark Technology Co., Ltd.
- Company Name: Guangxi Weili Ark Technology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced inspection of Guangxi Weili Ark Technology Co., Ltd. was conducted on July 26, 2018, under the regulatory framework of Good Manufacturing Practice for Medical Devices. The inspection revealed significant issues: the company's production plant and storage areas were undergoing renovation, and no production, inspection, or management personnel were present on-site. The company representative confirmed that production was suspended from July 24th to August 2nd, 2018, for these renovations. This situation prevented the inspection team from assessing ongoing compliance with manufacturing standards. Consequently, the regulatory body mandated specific actions. Before resuming production, Guangxi Weili Ark Technology Co., Ltd. must submit a written report to the Guangxi Zhuang Autonomous Region Food and Drug Administration. Production is only permitted to restart after the Guangxi Administration conducts a follow-up inspection and confirms that all requirements are met. Additionally, the Guangxi Administration is required to inform the National Medical Products Administration's medical device regulatory department once the company resumes operations.

Company: https://www.globalkeysolutions.net/companies/guangxi-weili-ark-technology-co-ltd/be4eed47-dfc9-4cef-b80a-b04744c0bda6/