# China NMPA Inspection - Shanghai Shangyi Kangge Medical Equipment Co., Ltd. - November 15, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-shangyi-kangge-medical-equipment-co-ltd/b86e01f8-5999-40f0-aa31-0b6541c2efea/
Source feed: China

> China NMPA unannounced inspection for Shanghai Shangyi Kangge Medical Equipment Co., Ltd. published November 15, 2016. Shanghai Shangyi Kangge Medical Equipment Co., Ltd. was identified as non-compliant with the Good Manufacturing Practice (GMP) for medical devices, in

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Shanghai Shangyi Kangge Medical Equipment Co., Ltd.
- Company Name: Shanghai Shangyi Kangge Medical Equipment Co., Ltd.
- Publication Date: 2016-11-15
- Product Type: Device
- Summary: Shanghai Shangyi Kangge Medical Equipment Co., Ltd. was identified as non-compliant with the Good Manufacturing Practice (GMP) for medical devices, indicating substantial deficiencies in its quality management system. The specific inspection dates were not provided within the document. Key issues included the use of altered sterilization parameters for products, leading to a mandatory recall of affected batches. In response, the company has ceased all production activities and is actively recalling products sterilized with the non-compliant parameters. Furthermore, Shanghai Shangyi Kangge Medical Equipment Co., Ltd. is mandated to undergo a new sterilization validation process to ensure future product safety and efficacy. Adhering to the regulatory framework for medical device manufacturing, the company must submit a comprehensive written report to the Shanghai Municipal Food and Drug Administration. Production resumption is strictly contingent upon the Administration's verification that all specified requirements have been met, confirming full compliance with GMP standards and the rectification of all identified quality management system deficiencies. This process emphasizes a commitment to public health and product integrity.

Company: https://www.globalkeysolutions.net/companies/shanghai-shangyi-kangge-medical-equipment-co-ltd/b663f56c-6d76-4e03-b34b-ae4c72de03f1/