# China NMPA Inspection - Xiamen Jindinghe Trading Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/xiamen-jindinghe-trading-co-ltd/42370576-6846-4b40-94d1-6e64c45c3a99
Source feed: China

> China NMPA unannounced inspection for Xiamen Jindinghe Trading Co., Ltd. published January 10, 2018. An unannounced inspection of Xiamen Jindinghe Trading Co., Ltd. was conducted by the NMPA from November 22nd to November 23rd, 2017. The inspection, b

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Xiamen Jindinghe Trading Co., Ltd.
- Company Name: Xiamen Jindinghe Trading Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Xiamen Jindinghe Trading Co., Ltd. was conducted by the NMPA from November 22nd to November 23rd, 2017. The inspection, based on the *Good Manufacturing Practice for Medical Devices*, revealed five deficiencies, including two critical and three general issues, concerning the company's operations in Class II and Class III medical devices.Critical violations included the quality manager's inability to fully and independently perform duties, with responsibilities for various product categories fragmented among multiple individuals. Additionally, purchase records for certain products, such as absorbable ligation clips, were incomplete, lacking essential supplier information.General deficiencies involved the company's warehouse, which was found to be inadequately laid out and constructed. The storage area for medical devices was not properly enclosed or isolated, co-mingling with non-medical goods belonging to other companies. Furthermore, the warehouse lacked essential insect and rodent control facilities. The company also failed to appoint dedicated personnel for monitoring and reporting medical device adverse events, as mandated by regulations.As a result, the Fujian Provincial Food and Drug Administration has ordered Xiamen Jindinghe Trading Co., Ltd. to rectify these issues within a specified period, in accordance with the *Regulations on the Supervision and Administration of Medical Devices*. Follow-up inspections will be conducted, and relevant information will be reported to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/xiamen-jindinghe-trading-co-ltd/d425c95d-884a-41dd-a8df-52a0064636ae