# China NMPA Inspection - Guangzhou Jiayuan Medical Reagent Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-jiayuan-medical-reagent-co-ltd/94ef4bac-08de-46d7-9663-2181e4b3653e/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Jiayuan Medical Reagent Co., Ltd. published January 09, 2018. An unannounced inspection of Guangzhou Jiayuan Medical Reagent Co., Ltd. was conducted by regulatory authorities from November 20th to November 21st, 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangzhou Jiayuan Medical Reagent Co., Ltd.
- Company Name: Guangzhou Jiayuan Medical Reagent Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Guangzhou Jiayuan Medical Reagent Co., Ltd. was conducted by regulatory authorities from November 20th to November 21st, 2017. The inspection aimed to assess the company's adherence to the *Good Manufacturing Practice for Medical Devices*.

During the assessment, five general deficiencies were identified across several key areas of the company's quality management system. Significant issues included insufficient training for quality management personnel on the computer management system, resulting in inaccurate initial supplier information, such as incorrect business scope entries. An inappropriately marked inspection area within the ambient temperature warehouse was also noted.

A critical finding was an expired quality assurance agreement with supplier BD Medical Devices (Shanghai) Co., Ltd., covering imported products like the "Lymphocyte Subset Detection Kit." Furthermore, receiving personnel failed to consistently confirm and sign for transportation methods or product compliance upon receipt, as demonstrated by an unsigned delivery for a "Rotavirus (Group A)/Adenovirus Detection Kit." Lastly, temperature and humidity records in the ambient temperature warehouse were incomplete, with data only recorded up to November 16th, 2017.

In response to these findings, the Guangdong Provincial Food and Drug Administration has been mandated to require Guangzhou Jiayuan Medical Reagent Co., Ltd. to rectify all identified issues within a specified period, followed by subsequent follow-up inspections. Upon successful completion of these corrective actions, the administration must report the rectification details to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/guangzhou-jiayuan-medical-reagent-co-ltd/74a4a68f-9bce-4d2d-805b-bf769939c32c/