# China NMPA Inspection - Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd. - October 30, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hangzhou-hu-qing-yu-tang-pharmaceutical-technology-co-ltd/9b5b2232-10c0-467c-8dab-5913c1962b7d/
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> China NMPA unannounced inspection for Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd. published October 30, 2018. An unannounced inspection of Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd., conducted on October 17-18, 2018, revealed significant non-

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd.
- Company Name: Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd.
- Publication Date: 2018-10-30
- Product Type: Device
- Summary: An unannounced inspection of Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd., conducted on October 17-18, 2018, revealed significant non-compliance with Good Manufacturing Practice for Medical Devices. The inspection identified numerous general defects across several critical areas. Key issues included deficiencies in facility control, such as inadequate insect and rodent prevention in cleaning workshops and improper management of non-conforming product storage. A major area of concern was document control, where inconsistencies were found between process specifications, procedures were not updated following equipment changes, and external regulatory documents like medical device recall regulations were not fully incorporated, leading to unrevised internal systems. Furthermore, the company exhibited unstandardized and incomplete quality records, including missing signatures on internal audit reports. Supplier management was also flawed, with discrepancies between approved supplier lists and actual suppliers, alongside a lack of supplier evaluations and ambiguous procurement specifications in contracts. Process control issues encompassed a failure to identify and confirm special processes like product sealing, incomplete operational procedures, and missing critical parameters in production records. Finally, the product sample retention and observation system was deemed inadequate, lacking clear definitions and corresponding records. In response, the Zhejiang Provincial Food and Drug Administration mandated that Hangzhou Hu Qing Yu Tang Pharmaceutical Technology Co., Ltd. rectify all identified issues promptly, assess product safety risks, and initiate product recalls for any items posing hazards, in accordance with the 'Regulations on the Recall of Medical Devices.' Follow-up inspections may be conducted, and a report will be submitted to the National Medical Products Administration upon completion of rectification.

Company: https://www.globalkeysolutions.net/companies/hangzhou-hu-qing-yu-tang-pharmaceutical-technology-co-ltd/3ad9cbc4-e445-44ea-9021-5af77cedc900/