# China NMPA Inspection - Foshan Boxin Biotechnology Co., Ltd. - April 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/foshan-boxin-biotechnology-co-ltd/57e88357-cccf-48e6-885a-fb81a0c564fd/
Source feed: China

> China NMPA unannounced inspection for Foshan Boxin Biotechnology Co., Ltd. published April 26, 2016. An important report, published on April 26, 2016, detailed the findings of an unannounced inspection conducted on Foshan Boxin Biotechnology Co., Ltd.

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Foshan Boxin Biotechnology Co., Ltd.
- Company Name: Foshan Boxin Biotechnology Co., Ltd.
- Publication Date: 2016-04-26
- Product Type: devices
- Summary: An important report, published on April 26, 2016, detailed the findings of an unannounced inspection conducted on Foshan Boxin Biotechnology Co., Ltd. The inspection, overseen by the National Medical Products Administration (NMPA) and the Guangdong Provincial Food and Drug Administration, revealed significant operational issues at the company. Foshan Boxin Biotechnology Co., Ltd. was found to be non-compliant with the fundamental requirements of the Good Manufacturing Practice for Medical Devices. Specifically, the regulatory body identified substantial deficiencies within the company's quality management system, indicating a failure to uphold essential standards for medical device production. These violations suggest potential risks to product quality, safety, and overall efficacy. In response to these critical findings, the Guangdong Provincial Food and Drug Administration has mandated Foshan Boxin Biotechnology Co., Ltd. to rectify all identified deficiencies within a specified timeframe. This directive emphasizes the regulatory commitment to ensuring that medical device manufacturers adhere strictly to national quality and safety standards, thereby safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/foshan-boxin-biotechnology-co-ltd/2a52c6d0-a641-41f1-8b1c-9f80a4af9bfd/