# China NMPA Inspection - Jiangsu Youchuang Biomedical Technology Co., Ltd. - October 12, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-youchuang-biomedical-technology-co-ltd/563a2e93-75ad-4e23-901c-c00dac505c7a/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Youchuang Biomedical Technology Co., Ltd. published October 12, 2017. Jiangsu Youchuang Biomedical Technology Co., Ltd. underwent an unannounced compliance inspection from September 14 to September 15, 2017. The inspecti

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Youchuang Biomedical Technology Co., Ltd.
- Company Name: Jiangsu Youchuang Biomedical Technology Co., Ltd.
- Publication Date: 2017-10-12
- Product Type: Device
- Summary: Jiangsu Youchuang Biomedical Technology Co., Ltd. underwent an unannounced compliance inspection from September 14 to September 15, 2017. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, identified several key violations. Issues included the presence of foreign material (paper) in a Class 100,000 cleanroom air outlet and a lack of documented procedures for replacing cleanroom air conditioning filters. The company also failed to properly manage document versions, with both old and new versions of the "Qualified Supplier List" being simultaneously effective without proper control. Furthermore, incoming inspection records for packaging materials lacked critical details such as initial contamination culture medium batch numbers, culture conditions, and negative control records. Undocumented regulations for the storage and preparation of chemical reagents used in purified water testing were also noted. As a result, the company is required to rectify all identified deficiencies promptly. The Jiangsu Provincial Food and Drug Administration will conduct follow-up inspections, mandate a comprehensive assessment of product safety risks, and require the recall of any potentially hazardous products. The provincial administration must then report the rectification progress to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/jiangsu-youchuang-biomedical-technology-co-ltd/be19b149-e000-49dd-81a2-a68becf2c3c4/