# China NMPA Inspection - Shenyang Huinayuan Trading Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shenyang-huinayuan-trading-co-ltd/f948960a-0b7b-4ac1-be36-bf43c906f306/
Source feed: China

> China NMPA unannounced inspection for Shenyang Huinayuan Trading Co., Ltd. published January 09, 2018. Shenyang Huinayuan Trading Co., Ltd. was subjected to an unannounced NMPA inspection from November 20-21, 2017. Based on the 《Good Manufacturing Pract

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shenyang Huinayuan Trading Co., Ltd.
- Company Name: Shenyang Huinayuan Trading Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: Shenyang Huinayuan Trading Co., Ltd. was subjected to an unannounced NMPA inspection from November 20-21, 2017. Based on the 《Good Manufacturing Practice for Medical Devices》 and 《Measures for the Supervision and Administration of Medical Device Operations》, the inspection identified 13 deficiencies, including 5 critical and 8 general issues, indicating a severely inadequate quality management system.

Key violations included the absence of a supplier qualification review system and a quality management self-inspection system. Critical documentation, such as records for returns, measuring instrument usage and calibration, and quality system assessments, was missing. Personnel-related deficiencies encompassed a lack of training plans, records, and employee health documentation. Facility issues involved water seepage in the warehouse and no designated storage for packaging materials. The company also failed to maintain proper records for infrastructure maintenance and instrument calibration.

Further problems were found in IT and supplier management. A dedicated computer management system was installed but not effectively utilized for purchasing, sales, and inventory. The company failed to provide adequate supplier qualification verification or purchase contracts for certain medical devices, and did not verify purchaser documentation or business scope. A significant regulatory non-compliance involved an unrecorded change in the person in charge on their Class II medical device operation filing certificate.

Consequently, the Liaoning Provincial Food and Drug Administration has ordered Shenyang Huinayuan Trading Co., Ltd. to immediately cease operations for rectification. Legal actions will be taken for violations under the Regulations on the Supervision and Administration of Medical Devices. A follow-up inspection is required, with the provincial authority reporting the rectification progress to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/shenyang-huinayuan-trading-co-ltd/e3b171f5-6e84-469d-bf14-4a1784854053/