# China NMPA Inspection - Hubei Sunshine Shenqi Medical Technology Co., Ltd. - December 22, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-sunshine-shenqi-medical-technology-co-ltd/956455f9-1b60-47bf-8745-78da05b33368
Source feed: China

> China NMPA unannounced inspection for Hubei Sunshine Shenqi Medical Technology Co., Ltd. published December 22, 2017. Hubei Yangguang Shenqi Medical Technology Co., Ltd. underwent an unannounced compliance inspection from November 23-24, 2017, based on Good Manufactur

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Hubei Sunshine Shenqi Medical Technology Co., Ltd.
- Company Name: Hubei Sunshine Shenqi Medical Technology Co., Ltd.
- Publication Date: 2017-12-22
- Product Type: Device
- Summary: Hubei Yangguang Shenqi Medical Technology Co., Ltd. underwent an unannounced compliance inspection from November 23-24, 2017, based on Good Manufacturing Practice for Medical Devices. The inspection revealed critical non-compliance issues, particularly concerning their YAG Laser Fiber Surgical Instrument.

Four serious deficiencies were identified. Notably, purchased optical fibers did not conform to registered product standards for length and core diameter, and no risk assessment was performed for this deviation. The company also lacked work instructions for aging tests and failed to conduct required factory inspections for key product characteristics like laser output power and transmission efficiency. Furthermore, management reviews were not conducted according to internal procedures.

Fifteen general deficiencies further highlighted systemic quality control failures. These included inconsistent quality objectives, inadequate environmental controls (e.g., insect prevention), missing operational and calibration records for production and testing equipment, and a significant lack of traceability for production activities, raw materials, and sales. Records for design and development approvals, risk management, and supplier quality agreements were also insufficient or absent. The company additionally demonstrated improper handling of nonconforming products, accepting them without proper review.

Given these pervasive quality management system problems, the Hubei Provincial Food and Drug Administration mandated that Hubei Yangguang Shenqi Medical Technology Co., Ltd. immediately cease production and rectify all deficiencies. The company must assess product safety risks, recall potentially hazardous products, and will face legal action for non-compliance with the "Regulations on the Supervision and Administration of Medical Devices." Production can only resume after complete rectification and a successful follow-up inspection. The status of their compliance efforts will be publicly disclosed.

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