# China NMPA Inspection - Sichuan Baiameng Bioactive Materials Co., Ltd. - July 20, 2022

Source: https://www.globalkeysolutions.net/records/china_inspection/sichuan-baiameng-bioactive-materials-co-ltd/1bd01bba-1e66-4a55-b0f7-90323125de75/
Source feed: China

> China NMPA unannounced inspection for Sichuan Baiameng Bioactive Materials Co., Ltd. published July 20, 2022. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Sichuan Bayamon Bioactive Materials Co., Ltd., with finding

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 34 of 2022 from the National Medical Products Administration regarding the results of a surprise inspection of Sichuan Bayamon Bioactive Materials Co., Ltd.
- Company Name: Sichuan Baiameng Bioactive Materials Co., Ltd.
- Publication Date: 2022-07-20
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Sichuan Bayamon Bioactive Materials Co., Ltd., with findings announced in July 2022. The inspection revealed serious deficiencies in the company's quality management system, indicating non-compliance with the Good Manufacturing Practice for Medical Devices and its Appendix on Implantable Medical Devices. Key violations included organizational issues where one production site (Area B) shared personnel and equipment with an affiliated company, leading to procedural inconsistencies. The microbiology laboratory's environmental control in Area B was also inadequate, using a regular air conditioner and portable ozone generator instead of compliant systems. Furthermore, the company failed to establish quality agreements with suppliers for certain materials and lacked clarity in procurement procedures. A critical production management issue was the absence of a sterilization validation report for their products. Consequently, the Sichuan Provincial Drug Administration has been ordered to suspend the company's production, address legal violations, assess product safety risks, and recall any potentially unsafe products. Production can only resume after all corrective actions are fully implemented and verified by a re-inspection from the provincial authority.

Company: https://www.globalkeysolutions.net/companies/sichuan-baiameng-bioactive-materials-co-ltd/643006c1-3990-45db-a4fb-2a45d320d96f/