# China NMPA Inspection - Changdong Medical Devices Group Co., Ltd. - September 28, 2023

Source: https://www.globalkeysolutions.net/records/china_inspection/changdong-medical-devices-group-co-ltd/65254b2f-f01c-4d5f-9389-d207278da8b0/
Source feed: China

> China NMPA unannounced inspection for Changdong Medical Devices Group Co., Ltd. published September 28, 2023. The National Medical Products Administration (NMPA) announced the findings of unannounced inspections conducted on four medical device enterprises on 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 49 of 2023 from the National Medical Products Administration regarding the results of unannounced inspections of four companies, including Changdong Medical Devices Group Co., Ltd.
- Company Name: Changdong Medical Devices Group Co., Ltd.
- Publication Date: 2023-09-28
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) announced the findings of unannounced inspections conducted on four medical device enterprises on September 27, 2023. Significant deficiencies in quality management systems were identified at Changdong Medical Device Group Co., Ltd., Henan Zhongjian Medical Device Co., Ltd., Henan Pfizer Biomedical Electronic Technology Co., Ltd., and Nanjing Yitebo Medical Technology Development Co., Ltd.

Key issues included inadequate personnel qualifications and training, equipment management discrepancies, failures in production record traceability and sterilization validation, and improper control of nonconforming products at Changdong. Henan Zhongjian faced broad issues spanning leadership familiarity with regulations, insufficient training, design and development documentation flaws, procurement inconsistencies, and ineffective adverse event monitoring. Henan Pfizer failed to report adverse event evaluations promptly and lacked comprehensive procedures. Nanjing Yitebo exhibited non-compliance in procurement traceability for bone tissue and incomplete quality control testing. 

All companies were deemed in serious violation of the Good Manufacturing Practice for Medical Devices (GMP). The NMPA mandates provincial drug regulatory authorities to order production suspension, address legal violations, assess product safety risks, and initiate recalls for potentially hazardous products. Production may resume only after full rectification and successful re-inspection.

Company: https://www.globalkeysolutions.net/companies/changdong-medical-devices-group-co-ltd/abbce35b-9a91-429c-b788-23c972d165b3/