# China NMPA Inspection - Guiyang Longquan Medical Equipment Co., Ltd. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guiyang-longquan-medical-equipment-co-ltd/842f3a20-768a-461a-8ae8-88982d1b2660/
Source feed: China

> China NMPA unannounced inspection for Guiyang Longquan Medical Equipment Co., Ltd. published August 01, 2018. An unannounced inspection of Guiyang Longquan Medical Device Co., Ltd. was conducted on July 10, 2018, under the regulatory framework of "Good Manufac

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guiyang Longquan Medical Device Co., Ltd.
- Company Name: Guiyang Longquan Medical Equipment Co., Ltd.
- Publication Date: 2018-08-01
- Product Type: Device
- Summary: An unannounced inspection of Guiyang Longquan Medical Device Co., Ltd. was conducted on July 10, 2018, under the regulatory framework of "Good Manufacturing Practice for Medical Devices." The inspection revealed significant compliance failures. The company's medical device production license had expired on February 28, 2017, with no renewal application submitted. Furthermore, the company had relocated prior to April 2018, and the registered production facility was found locked and deserted, with no personnel, raw materials, finished products, production equipment, or office supplies present, indicating a complete cessation of operations without proper regulatory notification. As a result of these critical findings, stringent actions are required. Guiyang Longquan Medical Device Co., Ltd. must submit a written report to the Guizhou Provincial Food and Drug Administration before any potential resumption of production. Production activities are strictly prohibited until the Guizhou Provincial Administration inspects the new premises, confirms compliance, and issues a valid production license. The Guizhou Provincial Food and Drug Administration is also mandated to promptly inform the National Medical Products Administration's medical device regulatory department about any developments regarding the company's operational resumption and is responsible for monitoring the quality and safety of any previously marketed products, ensuring Guiyang Longquan Medical Device Co., Ltd. upholds its fundamental responsibility for product quality and safety throughout the products' shelf life.

Company: https://www.globalkeysolutions.net/companies/guiyang-longquan-medical-equipment-co-ltd/d96054cb-342b-46dc-9fb5-3442209b1bd8/