# China NMPA Inspection - Hubei Qiushi Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-qiushi-medical-equipment-co-ltd/aa7e9b11-0964-47b6-870f-11b3a4f25694
Source feed: China

> China NMPA unannounced inspection for Hubei Qiushi Medical Equipment Co., Ltd. published January 09, 2018. An unannounced inspection of Hubei Qiushi Medical Device Co., Ltd., conducted from November 20th to 21st, 2017, revealed 13 general deficiencies again

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Qiushi Medical Device Co., Ltd.
- Company Name: Hubei Qiushi Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Hubei Qiushi Medical Device Co., Ltd., conducted from November 20th to 21st, 2017, revealed 13 general deficiencies against the Good Manufacturing Practice for Medical Devices. Key issues centered on inadequacies within the quality management system.

Personnel-related violations included expired employment contracts and health certificates for critical staff, including the quality manager and control officer. The quality management manager also lacked the stipulated educational background or professional qualifications. Furthermore, the company failed to provide technical training materials or after-sales service certificates for eight employees and neglected to maintain proper training plans and records for 2016 and 2017, despite internal policy requiring annual continuing education.

Warehouse operations showed significant non-conformities, such as the absence of a designated return area, with returned items incorrectly stored in the inspection zone. The warehouse also lacked essential rodent-proof, insect-proof, and fire-proof facilities. Improper segregation of products was noted, with disinfectant stored alongside medical devices and miscellaneous items cluttering the sample area. Critical equipment, like thermometers and hygrometers, had expired calibration certificates with no calibrated spares available, and temperature/humidity monitoring records for the cool storage area were missing. Inventory records were not maintained, and a documented acceptance procedure was not followed, as personnel neglected to print required acceptance records. Finally, external agreements, specifically purchase and sale contracts, failed to include provisions for after-sales service responsibilities.

The Hubei Provincial Food and Drug Administration is required to implement handling measures in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Company: https://www.globalkeysolutions.net/companies/hubei-qiushi-medical-equipment-co-ltd/8d5abf25-3329-4033-8b2e-7c4c6add5657