# China NMPA Inspection - Zhejiang Taiste Biotechnology Co., Ltd. - January 08, 2020

Source: https://www.globalkeysolutions.net/records/china_inspection/zhejiang-taiste-biotechnology-co-ltd/d0f87b3f-37af-4545-8685-22b69f1bcfce/
Source feed: China

> China NMPA unannounced inspection for Zhejiang Taiste Biotechnology Co., Ltd. published January 08, 2020. The National Medical Products Administration (NMPA) announced on January 8, 2020, the suspension of production for Zhejiang Taiste Biotechnology Co., 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 2 of 2020 from the National Medical Products Administration regarding the suspension of production and rectification of Zhejiang Taiste Biotechnology Co., Ltd.
- Company Name: Zhejiang Taiste Biotechnology Co., Ltd.
- Publication Date: 2020-01-08
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) announced on January 8, 2020, the suspension of production for Zhejiang Taiste Biotechnology Co., Ltd., following an unannounced inspection. The inspection revealed serious deficiencies across the company's quality management system, indicating non-compliance with the "Good Manufacturing Practice for Medical Devices" and its "Appendix for In Vitro Diagnostic Reagents."Key issues included a lack of formal job appointment documents for full-time inspection personnel, a critical lapse in organizational compliance. Production management showed significant traceability failures, as batch records for materials and equipment usage were inadequately linked, hindering comprehensive process tracking. In quality control, the inspection procedures for the γ-glutamyltransferase detection reagent were found deficient; they did not align with product technical requirements regarding inspection items, methods (e.g., sensitivity and linear range), or approved testing instruments. Furthermore, the company failed to conduct regular management reviews as stipulated by its own procedures, specifically overlooking a non-compliance issue concerning a gamma-glutamyl transferase assay kit identified in a national supervision and sampling inspection.As a result, the NMPA has ordered the company to immediately suspend production for comprehensive rectification. Zhejiang Taiste Biotechnology is required to assess product safety risks and recall any potentially hazardous products in accordance with medical device recall regulations. The company must implement thorough corrective actions and will face stringent follow-up inspections. Production resumption is contingent upon passing a re-inspection by the Zhejiang Provincial Medical Products Administration, with further violations subject to severe penalties under medical device supervision regulations.

Company: https://www.globalkeysolutions.net/companies/zhejiang-taiste-biotechnology-co-ltd/7458bb36-7a86-4fb1-b706-4fb42b4a0354/