# China NMPA Inspection - Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. - July 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-wanhe-plastic-surgery-materials-co-ltd/7865d690-1a6b-45d2-b70c-caffc96906ee/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. published July 14, 2017. The State Food and Drug Administration conducted an unannounced inspection of Guangzhou Wanhe Plastic Surgery Materials Co., Ltd., prior to July 14, 2

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 108 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Guangzhou Wanhe Plastic Surgery Materials Co., Ltd.
- Company Name: Guangzhou Wanhe Plastic Surgery Materials Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: devices
- Summary: The State Food and Drug Administration conducted an unannounced inspection of Guangzhou Wanhe Plastic Surgery Materials Co., Ltd., prior to July 14, 2017. The inspection revealed significant deficiencies in the company's quality management system, indicating non-compliance with the "Medical Quality Management Standard" (GMP for medical devices) and other relevant regulations. Key violations included improper cleanroom ventilation due to obstructed return air vents and storage, and a purified water storage tank lacking essential locking/sealing mechanisms and a breather. Document management was inadequate, with critical testing instruments, scales, and temperature chambers missing usage records. Production management issues were extensive, encompassing deviations from established sealing process parameters, absence of protective devices for hazardous materials like petroleum ether, and unspecified cleaning methods for dispensing tubing. Furthermore, the company failed to fully validate its sterilization process, specifically omitting product softness evaluation post-irradiation, and neglected to define storage periods for critical semi-finished products. As a result, Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. has been ordered to immediately cease production for rectification. They must assess product safety risks and recall any potentially unsafe products. Production can only resume after all corrective actions are completed and verified through a successful follow-up inspection by the provincial food and drug administration.

Company: https://www.globalkeysolutions.net/companies/guangzhou-wanhe-plastic-surgery-materials-co-ltd/f9e16c36-f342-40d4-a414-014b94306cbe/