# China NMPA Inspection - Jiangsu Weizhen Biomedical Technology Co., Ltd. - May 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-weizhen-biomedical-technology-co-ltd/063939ff-0d53-47ef-b22f-7d126c98fe0a/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Weizhen Biomedical Technology Co., Ltd. published May 28, 2018. An unannounced compliance inspection of Jiangsu Weizhen Biomedical Technology Co., Ltd. on May 10, 2018, revealed significant issues. The inspection, 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Weizhen Biomedical Technology Co., Ltd.
- Company Name: Jiangsu Weizhen Biomedical Technology Co., Ltd.
- Publication Date: 2018-05-28
- Product Type: Device
- Summary: An unannounced compliance inspection of Jiangsu Weizhen Biomedical Technology Co., Ltd. on May 10, 2018, revealed significant issues. The inspection, based on Good Manufacturing Practice for Medical Devices and its Appendix for In Vitro Diagnostic Reagents, found that the company's original production address (2nd and 3rd Floors, Building 2, No. 68 Xinqing Street) was demolished, with no personnel, production, or equipment present. The company had previously applied for a production site change in August 2017 to a new address. However, a prior inspection of this new location by the Jiangsu Provincial Food and Drug Administration on April 26, 2018, identified deficiencies, meaning the company had not yet obtained the required production license address change permit. The company submitted a "Statement of the Company's Situation" regarding these findings. To resume operations, Jiangsu Weizhen Biomedical Technology Co., Ltd. must first acquire the production license address change permit. A written report detailing compliance must be submitted to the Jiangsu Provincial Food and Drug Administration. Production can only recommence after the Provincial Administration conducts a further inspection and confirms the new address meets all regulatory requirements. The Provincial Administration is also responsible for informing the National Medical Products Administration when the company resumes production.

Company: https://www.globalkeysolutions.net/companies/jiangsu-weizhen-biomedical-technology-co-ltd/20789ff2-32c6-4aa2-a42a-edb22ddeca64/