# 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/f9a1d53c-928f-492e-8a30-9a870ef6fe34/
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> China NMPA unannounced inspection for Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. published July 14, 2017. On July 12, 2017, the State Food and Drug Administration announced findings from a recent unannounced inspection of Guangzhou Wanhe Plastic Surgery Ma

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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: Device
- Summary: On July 12, 2017, the State Food and Drug Administration announced findings from a recent unannounced inspection of Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. The inspection revealed significant deficiencies in the company's quality management system, indicating a failure to comply with the Good Manufacturing Practice for Medical Devices and related appendices.

Key violations included:
1.  **Plant and Facilities:** Cleanroom return air vents were blocked or improperly relocated, and chemical reagents were stored inappropriately within cleanroom cabinets.
2.  **Equipment:** The purified water storage tank lacked essential locking, sealing, and respiration devices.
3.  **Document Management:** Critical usage records were absent for outgoing testing instruments, intermediate inspection equipment, electronic scales, and constant temperature chambers.
4.  **Production Management:** Actual production operations, specifically for hot-pressing, deviated from specified process parameters. The company failed to implement protective measures for hazardous substances like petroleum ether, neglected to specify cleaning methods for dispensing tubing, conducted incomplete validation for product irradiation sterilization (missing evaluation of product softness), and had not determined appropriate storage periods for semi-finished products.

These serious deficiencies led the State Food and Drug Administration to order Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. to immediately cease production and undertake comprehensive rectification. The company must also assess product safety risks, recall any potentially unsafe products in accordance with the Regulations on the Recall of Medical Devices, and can only resume production after successfully completing all corrective actions and passing a subsequent provincial-level inspection.

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