# China NMPA Inspection - Taipu Bioscience (China) Co., Ltd. - April 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/taipu-bioscience-china-co-ltd/b28e6cd9-4119-4c3b-9d89-301bca40f987/
Source feed: China

> China NMPA unannounced inspection for Taipu Bioscience (China) Co., Ltd. published April 26, 2016. A surprise inspection conducted by the Fujian Provincial Food and Drug Administration on Taipu Bioscience (China) Co., Ltd. led to a report published 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight inspection of Techbio Biosciences (China) Co., Ltd.
- Company Name: Taipu Bioscience (China) Co., Ltd.
- Publication Date: 2016-04-26
- Product Type: devices
- Summary: A surprise inspection conducted by the Fujian Provincial Food and Drug Administration on Taipu Bioscience (China) Co., Ltd. led to a report published on April 26, 2016. The inspection identified critical non-compliance with regulatory requirements governing the manufacture of medical devices. Specifically, the company's actions were found to be inconsistent with the Good Manufacturing Practice (GMP) for Medical Devices, and its overall quality management system exhibited notable deficiencies. These issues suggest a failure to uphold essential quality and safety protocols mandated for the production of healthcare products.

The regulatory framework underpinning these findings is the Good Manufacturing Practice for Medical Devices, a crucial standard designed to ensure products are consistently produced and controlled according to quality standards. In response to these significant violations, the Fujian Provincial Food and Drug Administration has issued a formal directive to Taipu Bioscience (China) Co., Ltd. The company is now mandated to undertake comprehensive corrective actions to rectify all identified deficiencies within a specified period. This required action aims to bring the company's operations into full alignment with the Good Manufacturing Practice for Medical Devices, thereby safeguarding product quality and patient safety in China's medical device sector.

Company: https://www.globalkeysolutions.net/companies/taipu-bioscience-china-co-ltd/0895ab13-ff4b-496e-9b29-ae1ec28338b9/