# China NMPA Inspection - Liaoning Kaipu Medical Systems Co., Ltd. - April 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/liaoning-kaipu-medical-systems-co-ltd/27e8a6e9-fb76-41f1-9b38-085a96e83f99/
Source feed: China

> China NMPA unannounced inspection for Liaoning Kaipu Medical Systems Co., Ltd. published April 26, 2016. An important report released by the National Medical Products Administration (NMPA) on April 26, 2016, detailed the findings of an unannounced inspect

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Liaoning Kaipu Medical Systems Co., Ltd.
- Company Name: Liaoning Kaipu Medical Systems Co., Ltd.
- Publication Date: 2016-04-26
- Product Type: devices
- Summary: An important report released by the National Medical Products Administration (NMPA) on April 26, 2016, detailed the findings of an unannounced inspection conducted on Liaoning Kaipei Medical Systems Co., Ltd. The inspection revealed substantial issues concerning the company's operational adherence to regulatory standards. Specifically, Liaoning Kaipei Medical Systems Co., Ltd. was found to be non-compliant with critical aspects of the Good Manufacturing Practice for Medical Devices, which serves as the fundamental regulatory framework for ensuring medical product quality and safety. Furthermore, the audit identified notable deficiencies within the company's established quality management system. These shortcomings indicate a failure to maintain essential standards governing manufacturing processes and product control. As a direct consequence of these findings, the Liaoning Provincial Food and Drug Administration has officially mandated Liaoning Kaipei Medical Systems Co., Ltd. to implement comprehensive corrective actions and rectify all identified deficiencies within a specified timeframe. This regulatory action emphasizes the importance of stringent oversight to ensure compliance with medical device manufacturing standards and protect public health.

Company: https://www.globalkeysolutions.net/companies/liaoning-kaipu-medical-systems-co-ltd/dd2b79d9-29a5-49d8-9e61-9b9f4f9c68d5/