# China NMPA Inspection - Liaoning Yinyi Biotechnology Co., Ltd. - April 27, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/liaoning-yinyi-biotechnology-co-ltd/2dc462d1-2f9d-4685-8c84-20fe198176b7/
Source feed: China

> China NMPA unannounced inspection for Liaoning Yinyi Biotechnology Co., Ltd. published April 27, 2017. An official report, issued on April 27, 2017, detailed the findings of an unannounced inspection conducted at Liaoning Yinyi Biotechnology Co., Ltd. T

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Liaoning Yinyi Biotechnology Co., Ltd.
- Company Name: Liaoning Yinyi Biotechnology Co., Ltd.
- Publication Date: 2017-04-27
- Product Type: devices
- Summary: An official report, issued on April 27, 2017, detailed the findings of an unannounced inspection conducted at Liaoning Yinyi Biotechnology Co., Ltd. The inspection revealed significant deviations from established regulatory requirements governing medical device manufacturing. Specifically, the company's practices were found to be non-compliant with the relevant provisions of the Good Manufacturing Practice for Medical Devices. Furthermore, the inspection identified substantial deficiencies within Liaoning Yinyi Biotechnology Co., Ltd.'s overall quality management system, indicating a lack of robust controls necessary for ensuring product quality and safety. The regulatory framework underpinning this assessment is the Good Manufacturing Practice for Medical Devices, a critical standard designed to ensure the consistent production and control of medical devices according to quality standards. In response to these critical findings, the Liaoning Provincial Food and Drug Administration has mandated specific actions. Liaoning Yinyi Biotechnology Co., Ltd. has been formally ordered to undertake comprehensive rectification measures to address all identified deficiencies within a defined period, thereby bringing its operations into full compliance with applicable medical device manufacturing regulations.

Company: https://www.globalkeysolutions.net/companies/liaoning-yinyi-biotechnology-co-ltd/06bc8b44-6139-4abf-9aaf-141f2568c051/