# China NMPA Inspection - Abogen Biosciences (Hangzhou) Co., Ltd. - July 19, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/abogen-biosciences-hangzhou-co-ltd/b901010c-415f-4fa5-a675-238421233a7a/
Source feed: China

> China NMPA unannounced inspection for Abogen Biosciences (Hangzhou) Co., Ltd. published July 19, 2016. An unannounced inspection conducted by the Zhejiang Provincial Food and Drug Administration identified significant issues at Abogen Biosciences (Hangz

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Abogen Biosciences (Hangzhou) Co., Ltd.
- Company Name: Abogen Biosciences (Hangzhou) Co., Ltd.
- Publication Date: 2016-07-19
- Product Type: devices
- Summary: An unannounced inspection conducted by the Zhejiang Provincial Food and Drug Administration identified significant issues at Abogen Biosciences (Hangzhou) Co., Ltd. The official report, published on July 19, 2016, detailed that the company's operations were not in compliance with the essential requirements of the Good Manufacturing Practice for Medical Devices. Specifically, the inspection revealed multiple deficiencies within Abogen Biosciences' quality management system. The regulatory framework governing medical device production mandates strict adherence to GMP standards to ensure product safety, efficacy, and quality. The identified shortcomings indicate that the company's current practices fall short of these critical benchmarks, potentially impacting the reliability and safety of their manufactured medical devices. As a direct consequence of these findings, the Zhejiang Provincial Food and Drug Administration has issued a clear directive to Abogen Biosciences (Hangzhou) Co., Ltd. The company is now required to undertake prompt and comprehensive rectification of all identified deficiencies within a specified timeframe. This mandatory action is intended to bring their operations into full alignment with the Good Manufacturing Practice for Medical Devices, thereby strengthening their quality management system and ensuring compliance with national regulatory standards. This oversight by the National Medical Products Administration (NMPA) underscores the commitment to public health and product integrity in the medical device sector.

Company: https://www.globalkeysolutions.net/companies/abogen-biosciences-hangzhou-co-ltd/93a61ee6-010f-4c06-86d9-6ef778e0949f/