# China NMPA Inspection - Guangzhou Runhong Pharmaceutical Technology Co., Ltd. - August 12, 2020

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-runhong-pharmaceutical-technology-co-ltd/17866dc0-4480-46dc-8ef9-ef2cc27e2b9e/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Runhong Pharmaceutical Technology Co., Ltd. published August 12, 2020. The National Medical Products Administration (NMPA) announced unannounced inspections of four medical device manufacturers, revealing significant qual

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 54 of 2020 from the National Medical Products Administration regarding the results of unannounced inspections of four companies, including Guangzhou Runhong Pharmaceutical Technology Co., Ltd.
- Company Name: Guangzhou Runhong Pharmaceutical Technology Co., Ltd.
- Publication Date: 2020-08-12
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) announced unannounced inspections of four medical device manufacturers, revealing significant quality management system deficiencies. The inspections, announced on August 12, 2020, found widespread non-compliance with the "Good Manufacturing Practice for Medical Devices" and its appendix for sterile devices.

Guangzhou Runhong Pharmaceutical Technology Co., Ltd. exhibited issues across design and development, procurement, production management, and quality control, including missing design records, inadequate supplier quality agreements, deviations from registered production processes, missing batch records, and lack of sterilization documentation.

Nanchang Beotech Medical Technology Co., Ltd. failed in maintaining proper plant and facilities, with unfiltered air conditioning exhaust impacting environmental control. Its design and development processes lacked sufficient evaluation data for material changes affecting product safety and effectiveness.

Jiangxi Yikang Medical Device Group Co., Ltd. had procurement traceability issues, with raw materials lacking essential identifying information. Equipment maintenance was also deficient, evidenced by a damaged pressure gauge.

Henan Anbang Medical Supplies Co., Ltd. failed to sign quality agreements with key suppliers and demonstrated poor production management, including unrecorded raw material whereabouts and lack of control and confirmation for special production processes like anticoagulant addition.

In response, the NMPA has ordered all four companies to immediately cease production for rectification. They must assess product safety risks, recall affected items, and face legal consequences for regulatory violations. Production can only resume after provincial drug regulatory authorities verify full rectification through re-inspection, with progress to be reported to the NMPA.

Company: https://www.globalkeysolutions.net/companies/guangzhou-runhong-pharmaceutical-technology-co-ltd/ce0b2e2d-a3da-4ef5-b05d-376bb95a7622/