# China NMPA Inspection - Zhejiang Judian Medical Equipment Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/zhejiang-judian-medical-equipment-co-ltd/8db3a767-e3ce-49b7-82d9-010279fb4aeb/
Source feed: China

> China NMPA unannounced inspection for Zhejiang Judian Medical Equipment Co., Ltd. published January 10, 2018. An unannounced inspection of Zhejiang Judian Medical Device Co., Ltd. was conducted by the FDA NMPA on November 20-21, 2017, to assess compliance with

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Zhejiang Judian Medical Equipment Co., Ltd.
- Company Name: Zhejiang Judian Medical Equipment Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Zhejiang Judian Medical Device Co., Ltd. was conducted by the FDA NMPA on November 20-21, 2017, to assess compliance with the Good Manufacturing Practice for Medical Devices. The inspection identified a total of six deficiencies, including three critical and three general issues.

Critical violations included the company's quality management system and procedures not being effectively implemented or properly documented with required signatures. Furthermore, purchase and sales records for an allogeneic bone repair material lacked essential authentication, such as handler signatures and the company seal, with only a photocopy of the product qualification certificate available. A significant data integrity concern was also noted, where the computer system allowed unauthorized modifications to batch numbers, including changes to production and expiration dates, without proper access controls or audit trails.

General defects highlighted included quality management personnel's unfamiliarity with relevant medical device regulations and the absence of a 2017 training plan and records. The company also failed to consistently manage non-conforming products, specifically an expired hemostatic patch, which was inconsistently handled by either destruction or re-labeling as a display sample, contrary to internal procedures. Additionally, the company sold a Class II hemostatic patch to a distributor whose business license did not encompass that product category at the time of sale.

As a result, the Zhejiang Provincial Food and Drug Administration has been directed to order the company to rectify these issues promptly, conduct follow-up inspections, and report the corrective actions to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/zhejiang-judian-medical-equipment-co-ltd/82664ce2-da96-4d03-8448-dce9b41f9ca8/