# China NMPA Inspection - Weifang 3D Biotechnology Group Co., Ltd. - January 08, 2020

Source: https://www.globalkeysolutions.net/records/china_inspection/weifang-3d-biotechnology-group-co-ltd/28289e73-9b13-4cd2-a18a-9a848c0f1448/
Source feed: China

> China NMPA unannounced inspection for Weifang 3D Biotechnology Group Co., Ltd. published January 08, 2020. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Weifang Sanwei Biotechnology Group Co., Ltd., leading to an

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 3 of 2020 from the National Medical Products Administration regarding the suspension of production and rectification of Weifang Sanwei Bioengineering Group Co., Ltd.
- Company Name: Weifang 3D Biotechnology Group Co., Ltd.
- Publication Date: 2020-01-08
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Weifang Sanwei Biotechnology Group Co., Ltd., leading to an announcement on January 8, 2020, regarding severe deficiencies in the company's quality production management system. The inspection revealed critical non-compliance with the "Good Manufacturing Practice for Medical Devices" and its "Appendix: In Vitro Diagnostic Reagents."

Key violations included significant issues across multiple areas. In Plant and Facilities, no production equipment for colloidal gold products, such as hepatitis C virus antibody detection kits, was found at the site, failing to meet required equipment standards. For Document Management, the company's departmental management review records inadequately assessed the continued suitability of its quality policy, rather than just its initial formulation. Furthermore, Quality Control was deficient; the "Product Inspection Report" for "Batch 20180501 Anti-HCV Colloidal Gold Kit" did not adhere to the company's own standard operating procedures for finished product inspection.

As a result of these serious findings, the NMPA has mandated the company to immediately suspend production for comprehensive rectification. Weifang Sanwei Biotechnology Group Co., Ltd. is also required to assess product safety risks and initiate recalls for any potentially hazardous products, in accordance with the "Regulations on the Recall of Medical Devices." Production cannot resume until the Shandong Provincial Medical Products Administration conducts and approves a re-inspection, ensuring all regulatory requirements are met. The NMPA will conduct follow-up inspections to ensure effective implementation of corrective actions, with severe legal consequences for any further violations of the "Regulations on the Supervision and Administration of Medical Devices."

Company: https://www.globalkeysolutions.net/companies/weifang-3d-biotechnology-group-co-ltd/9ff261c7-6f96-4e5c-8b40-1315a85c2313/