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

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-fukun-medical-equipment-trading-co-ltd/7be34541-ffd9-44d5-918a-db6674ade908/
Source feed: China

> China NMPA unannounced inspection for Hubei Fukun Medical Equipment Trading Co., Ltd. published January 09, 2018. An unannounced inspection of Hubei Fukun Medical Device Trading Co., Ltd. occurred from November 22-23, 2017. Based on the Good Manufacturing Practice

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Fukun Medical Equipment Trading Co., Ltd.
- Company Name: Hubei Fukun Medical Equipment Trading Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Hubei Fukun Medical Device Trading Co., Ltd. occurred from November 22-23, 2017. Based on the Good Manufacturing Practice for Medical Devices, the inspection uncovered nine general deficiencies. Key issues included the expiration of health certificates for critical quality and warehouse personnel, and the absence of a designated return area in the warehouse. The company also failed to maintain required records for infrastructure and equipment maintenance, and crucial environmental monitoring devices had not been calibrated since the company's establishment in July 2016.

Additional violations involved procedural lapses, such as missing receiving clerk signatures on delivery slips, and the omission of product batch or serial numbers on specific receiving and acceptance records. The company neglected to archive original sales authorization letters and the warehouse keeper failed to record essential product registration information during outbound verification. Furthermore, Hubei Fukun did not formalize agreements with suppliers or manufacturers regarding installation, maintenance, and technical training responsibilities for certain medical devices sold.

Consequently, the Hubei Provincial Food and Drug Administration was instructed to order the company to rectify these issues within a defined period, conduct follow-up inspections, and report the resolution to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/hubei-fukun-medical-equipment-trading-co-ltd/356ccfbc-a1a1-4193-a40e-0032d335b8d3/