# China NMPA Inspection - Sichuan Jiujiu Tianmu Medical Equipment Co., Ltd. - November 20, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/sichuan-jiujiu-tianmu-medical-equipment-co-ltd/0200a81b-0ca5-4942-b840-7bb4c3401696/
Source feed: China

> China NMPA unannounced inspection for Sichuan Jiujiu Tianmu Medical Equipment Co., Ltd. published November 20, 2017. An unannounced compliance inspection of Sichuan Jiujiu Tianmu Medical Device Co., Ltd., producer of Dental X-ray Digital Tomography Equipment, was con

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Sichuan Jiujiu Tianmu Medical Equipment Co., Ltd.
- Company Name: Sichuan Jiujiu Tianmu Medical Equipment Co., Ltd.
- Publication Date: 2017-11-20
- Product Type: Device
- Summary: An unannounced compliance inspection of Sichuan Jiujiu Tianmu Medical Device Co., Ltd., producer of Dental X-ray Digital Tomography Equipment, was conducted on November 7, 2017. The inspection, based on Good Manufacturing Practice for Medical Devices, revealed that the company was in a state of production suspension, a status confirmed by the Mianyang Municipal Food and Drug Administration, following a suspension application submitted in July 2017. Significant operational deficiencies were identified. The majority of the company’s original key personnel, including the legal representative, management representative, production and inspection managers, and associated staff, had departed, leaving only seven employees primarily focused on third-party cooperation and after-sales service. Furthermore, the existing production and storage areas were found to be reduced in size and insufficient to support normal manufacturing assembly and component storage requirements. As a result, Sichuan Jiujiu Tianmu Medical Device Co., Ltd. is required to submit a comprehensive written report to the Sichuan Provincial Food and Drug Administration before any resumption of production. Manufacturing operations are strictly prohibited until the provincial administration verifies full compliance with regulatory requirements. The Sichuan Provincial Food and Drug Administration is also mandated to promptly inform the Medical Device Supervision Department of the State Administration for Market Regulation regarding the company's eventual resumption of production.

Company: https://www.globalkeysolutions.net/companies/sichuan-jiujiu-tianmu-medical-equipment-co-ltd/3d63ac28-2904-417d-a3bd-5deb44ce43e7/