# China NMPA Inspection - Hainan Shounanshan Ginseng Industry Co., Ltd. - March 15, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hainan-shounanshan-ginseng-industry-co-ltd/82e8ff9e-65c4-4930-8bc8-70c21e691345/
Source feed: China

> China NMPA unannounced inspection for Hainan Shounanshan Ginseng Industry Co., Ltd. published March 15, 2017. An inspection of Hainan Shounanshan Ginseng Industry Co., Ltd. was conducted by the National Food and Drug Administration Inspection Center and Hainan

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Hainan Shounanshan Ginseng Industry Co., Ltd.
- Company Name: Hainan Shounanshan Ginseng Industry Co., Ltd.
- Publication Date: 2017-03-15
- Product Type: Drugs
- Summary: An inspection of Hainan Shounanshan Ginseng Industry Co., Ltd. was conducted by the National Food and Drug Administration Inspection Center and Hainan Provincial Food and Drug Administration from October 10-12, 2016. The inspection was prompted by a market sampling issue involving "Dodder" traditional Chinese medicine (TCM) decoction pieces. The focus was on procurement, production, processing, and inspection processes for this product. The inspection revealed significant non-compliance with Good Manufacturing Practice (GMP) regulations and *Chinese Pharmacopoeia* quality standards. Key issues included the company's failure to properly inspect and record purchased raw material "Dodder" according to stipulated quality standards, and the absence of retained samples for raw materials. Furthermore, batch inspection records were found to be inaccurate, lacking original sampling and inspection details, and appeared to have been supplemented after market sampling. Similarly, batch production records were inaccurate or missing for the processing of *Cuscuta chinensis*, raising suspicions of direct repackaging and sale of purchased TCM decoction pieces without proper manufacturing oversight. As a result of these serious violations, the company was deemed non-compliant with pharmaceutical GMP regulations. The provincial drug administration has been directed to revoke Hainan Shounanshan Ginseng Industry Co., Ltd.'s GMP certificate and implement comprehensive risk control measures for all implicated products. This action underscores the critical importance of stringent adherence to regulatory requirements in pharmaceutical manufacturing.

Company: https://www.globalkeysolutions.net/companies/hainan-shounanshan-ginseng-industry-co-ltd/12f0a50e-af9a-4133-9303-7fbdd9736ec5/