# China NMPA Inspection - Anhui Tiankang Medical Technology Co., Ltd. - September 29, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-tiankang-medical-technology-co-ltd/c2dd6738-4490-495e-8de8-c2b3740ce1f5/
Source feed: China

> China NMPA unannounced inspection for Anhui Tiankang Medical Technology Co., Ltd. published September 29, 2016. An unannounced inspection of Anhui Tiankang Medical Technology Co., Ltd. was documented in a report published on September 29, 2016. This regulatory r

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Anhui Tiankang Medical Technology Co., Ltd.
- Company Name: Anhui Tiankang Medical Technology Co., Ltd.
- Publication Date: 2016-09-29
- Product Type: Device
- Summary: An unannounced inspection of Anhui Tiankang Medical Technology Co., Ltd. was documented in a report published on September 29, 2016. This regulatory review, conducted by the Anhui Provincial Food and Drug Administration, aimed to assess the company's adherence to essential manufacturing standards. The inspection identified critical non-compliances with the Good Manufacturing Practice for Medical Devices, highlighting significant deficiencies within the company's quality management system. These findings indicated that Anhui Tiankang Medical Technology Co., Ltd. failed to meet the rigorous operational and systemic requirements designed to ensure the quality, safety, and efficacy of medical devices. As a result, the Anhui Provincial Food and Drug Administration has issued a formal order requiring the company to implement comprehensive corrective actions. Anhui Tiankang Medical Technology Co., Ltd. is mandated to rectify all identified deficiencies within a specified period, ensuring its processes and quality systems are brought into full compliance with the established regulatory framework for medical device manufacturing. This directive emphasizes the regulatory commitment to upholding high standards for product quality and patient safety.

Company: https://www.globalkeysolutions.net/companies/anhui-tiankang-medical-technology-co-ltd/c6b04661-54e9-4c79-8eea-55c1112632ee/