# China NMPA Inspection - Sinocare Medical Science and Technology Co., Ltd. - April 27, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/sinocare-medical-science-and-technology-co-ltd/ecb164e3-45f3-4de2-8ee8-13185edbf6e1/
Source feed: China

> China NMPA unannounced inspection for Sinocare Medical Science and Technology Co., Ltd. published April 27, 2017. An important report, published on April 27, 2017, by the National Medical Products Administration (NMPA), details the findings from an unannounced ins

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Sinocare Medical Science and Technology Co., Ltd.
- Company Name: Sinocare Medical Science and Technology Co., Ltd.
- Publication Date: 2017-04-27
- Product Type: devices
- Summary: An important report, published on April 27, 2017, by the National Medical Products Administration (NMPA), details the findings from an unannounced inspection conducted at Sinocare Medical Technology Co., Ltd. The inspection revealed that the company's operational practices were not in compliance with the stringent requirements of the Good Manufacturing Practice for Medical Devices, a critical regulatory framework designed to ensure the quality, safety, and efficacy of medical products. Specifically, the audit identified significant deficiencies within Sinocare Medical Technology Co., Ltd.'s overall quality management system. These shortcomings indicate a failure to adequately implement and maintain the necessary controls and processes required for the responsible manufacturing of medical devices. Non-compliance with GMP regulations can compromise product integrity and patient safety, highlighting the seriousness of the findings. As a direct consequence of these violations, the Tianjin Municipal Market and Quality Supervision and Management Commission has issued an official order to Sinocare Medical Technology Co., Ltd. The company is now mandated to address and rectify all identified deficiencies within its quality management system and manufacturing practices. This rectification must occur within a specified period, emphasizing the regulatory body's commitment to ensuring adherence to national standards and protecting public health through robust oversight of medical device manufacturers.

Company: https://www.globalkeysolutions.net/companies/sinocare-medical-science-and-technology-co-ltd/76236c28-47c1-4fcf-8b46-de22c2afc2d8/