# China NMPA Drug Inspection - Anguo Shenghe Pharmaceutical Co., Ltd. - Amomum villosum

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/anguo-shenghe-pharmaceutical-co-ltd/8562a196-5395-4fe8-89c3-a7cede3199aa/
Source feed: China

> China NMPA drug inspection for Anguo Shenghe Pharmaceutical Co., Ltd. published December 29, 2017. Drug: Amomum villosum. An announcement from the State Administration for Market Regulation, published on December 29, 2017, reported significan

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 228 of 2017 from the State Administration of Traditional Chinese Medicine regarding 38 batches of substandard prepared slices of traditional Chinese medicine.
- Company Name: Anguo Shenghe Pharmaceutical Co., Ltd.
- Publication Date: 2017-12-29
- Drug Name: Amomum villosum
- Inspection Finding: The properties and content determination were substandard.
- Action Taken: Relevant provincial food and drug administration departments have taken control measures such as sealing and seizing, required enterprises to suspend sales and use, recall products, and make rectifications. An investigation will be launched into the illegal acts of producing and selling unqualified drugs.
- Summary: An announcement from the State Administration for Market Regulation, published on December 29, 2017, reported significant quality control failures in traditional Chinese medicine. Investigations by institutions like the China National Institutes for Food and Drug Control identified 38 batches of decoction pieces from 29 enterprises as unqualified. Key companies involved included Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd. and Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., among numerous others. Main violations stemmed from substandard product quality, particularly concerning appearance, identification, and content determination for products like Bletilla striata, Amomum villosum, Codonopsis pilosula, and Eupolyphaga sinensis. These issues violated standards outlined in the Pharmacopoeia of the People's Republic of China and relevant provincial processing specifications. In response, provincial food and drug administrations were mandated to implement control measures, including product sealing, seizure, sales suspension, and recalls. Operating under the "Drug Administration Law of the People's Republic of China," these departments are required to investigate the illegal production and sale, impose severe penalties on responsible manufacturers, and publicly disclose resolution outcomes within three months, emphasizing a strong commitment to drug quality and safety.

Company: https://www.globalkeysolutions.net/companies/anguo-shenghe-pharmaceutical-co-ltd/6e864cb9-f4ce-41d7-b132-26d3cd531050/