# China NMPA Drug Inspection - Guangxi Guigang Shennong Pharmaceutical Co., Ltd. - Isatis root

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangxi-guigang-shennong-pharmaceutical-co-ltd/3da07e6c-1ff1-4840-84dd-54b65e8af2cf/
Source feed: China

> China NMPA drug inspection for Guangxi Guigang Shennong Pharmaceutical Co., Ltd. published February 09, 2017. Drug: Isatis root. On February 9, 2017, China's State Administration for Market Regulation announced findings from drug testing institution

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 21 of 2017 from the State Administration of Traditional Chinese Medicine regarding 54 batches of substandard prepared slices of traditional Chinese medicine.
- Company Name: Guangxi Guigang Shennong Pharmaceutical Co., Ltd.
- Publication Date: 2017-02-09
- Drug Name: Isatis root
- Inspection Finding: The non-compliant items included appearance, content determination, and sulfur dioxide residue.
- Action Taken: Control measures such as sealing and seizing were taken, requiring enterprises to suspend sales and use, recall products and make rectifications; cases were filed and investigated for illegal acts of producing and selling substandard products, and penalty decisions were made, with relevant responsible persons punished.
- Summary: On February 9, 2017, China's State Administration for Market Regulation announced findings from drug testing institutions, revealing that 54 batches of traditional Chinese medicine decoction pieces from 46 companies, including Shanghai Huaying Pharmaceutical Co., Ltd., were substandard. Key violations encompassed deficiencies in product appearance, content determination, identification, and elevated sulfur dioxide residue, indicating non-compliance with the standards outlined in the *Pharmacopoeia of the People's Republic of China*. Specific issues involved Banlangen (Isatis root) and Angelica sinensis exhibiting multiple quality failures, Magnolia officinalis (Houpu) having improper content determination, and Scorpion (Quan Xie) failing on extractives. Operating under the 'Drug Administration Law of the People's Republic of China,' provincial food and drug administrations were mandated to implement immediate control measures. These included sealing and seizing products, suspending sales and usage, and initiating recalls. Additionally, administrations are required to investigate the illegal production and sale activities, issue penalty decisions within one month, report findings to the State Food and Drug Administration, and publicly disclose the penalties, which must also target responsible individuals. A process was also established for companies to challenge product authenticity, leading to further investigation and potential severe sanctions if claims are disproven.

Company: https://www.globalkeysolutions.net/companies/guangxi-guigang-shennong-pharmaceutical-co-ltd/83b421f4-283f-4945-b544-cf915ca03994/