# China NMPA Inspection - Hubei Sunshine Shenqi Medical Technology Co., Ltd. - December 18, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-sunshine-shenqi-medical-technology-co-ltd/237eb35c-3f2b-4278-9e69-4c6f515af34e/
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> China NMPA unannounced inspection for Hubei Sunshine Shenqi Medical Technology Co., Ltd. published December 18, 2017. Hubei Sunshine Shenqi Medical Technology Co., Ltd. was subject to a recent unannounced inspection by the State Food and Drug Administration, with find

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 208 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Hubei Sunshine Shenqi Medical Technology Co., Ltd.
- Company Name: Hubei Sunshine Shenqi Medical Technology Co., Ltd.
- Publication Date: 2017-12-18
- Product Type: Device
- Summary: Hubei Sunshine Shenqi Medical Technology Co., Ltd. was subject to a recent unannounced inspection by the State Food and Drug Administration, with findings announced on December 14, 2017. The inspection uncovered serious deficiencies across the company's quality management system, indicating non-compliance with the Good Manufacturing Practice for Medical Devices and related regulations. Major violations included insufficient records for testing equipment usage, calibration, maintenance, and repair, particularly for 2016. The company procured optical fibers that did not conform to registered product standards for length and core diameter, without conducting required risk assessments for these modifications. Procurement documentation also lacked clear acceptance criteria and procedures. Furthermore, critical production processes, such as aging tests, did not have proper work instructions, and factory inspections were incomplete, failing to cover all specified product standard items. Control of nonconforming products was inadequate, with instances of direct acceptance of faulty components without proper review. Lastly, the company failed to conduct regular management reviews as required to assess its quality management system. As a result, Hubei Sunshine Shenqi Medical Technology Co., Ltd. has been ordered to immediately cease production for comprehensive rectification. They must also assess all product safety risks and recall any potentially hazardous products. Production can only recommence after all corrective actions are completed and verified through a follow-up inspection by the provincial food and drug administration. Violations of medical device supervision regulations will face severe legal penalties.

Company: https://www.globalkeysolutions.net/companies/hubei-sunshine-shenqi-medical-technology-co-ltd/3c69dc5b-418d-439c-b4fd-ede164c4d4fe/