# 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/b6f4e7f6-8b64-458b-9f46-8cf7cbef8692/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. published July 14, 2017. An unannounced inspection by the State Food and Drug Administration on June 24, 2017, identified significant non-compliance at Guangzhou Wanhe Plastic

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio, Film and Television on urging Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. to suspend production and rectify problems found during flight inspections.
- Company Name: Guangzhou Wanhe Plastic Surgery Materials Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: Device
- Summary: An unannounced inspection by the State Food and Drug Administration on June 24, 2017, identified significant non-compliance at Guangzhou Wanhe Plastic Surgery Materials Co., Ltd., a manufacturer of Silicone Gel Breast Implants. Conducted under the "Measures for Unannounced Inspections of Drugs and Medical Devices," the inspection revealed serious deficiencies in the company's production quality management system.
The most critical violation involved a discrepancy between actual manufacturing operations and documented procedures. Specifically, hot-pressing process parameters for small caps used in product sealing were inconsistent with the specified "Sealing Process Operation Instruction," showing deviations in both temperature and pressure.
Seven general defects were also found, including a lack of usage records for testing instruments, obstructed cleanroom air vents, improper storage of chemicals, an unsealed purified water storage tank lacking a respirator, and the absence of adequate protective devices for flammable production materials like petroleum ether. These issues indicated a failure to adhere to the "Good Manufacturing Practice for Medical Devices" and its "Appendix: Implantable Medical Devices."
As a result, Guangzhou Wanhe Plastic Surgery Materials Co., Ltd. is mandated to immediately suspend production for rectification, in accordance with the "Regulations on the Supervision and Administration of Medical Devices." The company must address all identified violations, and its rectification progress and any regulatory actions must be publicly disclosed. Production can only resume after successful completion of all corrective actions and passing a follow-up inspection. The provincial administration is also required to enhance its daily oversight and ensure robust implementation of quality management responsibilities.

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