# China NMPA Drug Inspection - Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd. - Amomum villosum

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-qirentang-traditional-chinese-medicine-pieces-co-ltd/9bf25db0-8416-4bd6-a217-d77055add157/
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> China NMPA drug inspection for Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd. published December 29, 2017. Drug: Amomum villosum. On December 29, 2017, the China Food and Drug Administration (CFDA) announced significant quality control issues followi

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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: Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2017-12-29
- Drug Name: Amomum villosum
- Inspection Finding: The non-compliant items included appearance and content determination.
- Action Taken: Relevant provincial-level food and drug administration departments have taken control measures such as sealing and seizing goods, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The State Food and Drug Administration has instructed the provincial-level food and drug administration departments where the relevant entities are located to investigate the illegal acts of producing and selling substandard drugs by the aforementioned enterprises in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," and to publicly disclose the results of the handling of the relevant entities within three months, and to promptly report the relevant circumstances.
- Summary: On December 29, 2017, the China Food and Drug Administration (CFDA) announced significant quality control issues following the testing of 38 batches of traditional Chinese medicine (TCM) decoction pieces. Conducted by four national drug testing institutions, the inspections revealed substandard products from 29 enterprises, including Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd. and Beijing Bencao Fangyuan Pharmaceutical Co., Ltd. The primary violations involved critical TCM ingredients such as Bletilla striata, Amomum villosum, Codonopsis pilosula, and Eupolyphaga sinensis, which exhibited deficiencies in appearance, identification, and content determination. Under the "Drug Administration Law of the People's Republic of China" (Articles 73, 74, and 75), the CFDA mandated provincial food and drug administration departments to take immediate action. These actions included sealing and seizing non-compliant products, suspending sales, initiating recalls, and requiring rectification from the implicated companies. Furthermore, provincial authorities were instructed to thoroughly investigate the illegal acts, publicly disclose the investigation outcomes within three months, and report all findings promptly. The announcement also detailed a procedure for companies to contest product authenticity, which would lead to further investigation and potentially severe penalties for confirmed manufacturers.

Company: https://www.globalkeysolutions.net/companies/jiangxi-qirentang-traditional-chinese-medicine-pieces-co-ltd/bc7f8cb1-0f93-4edf-8db9-836c24e4fc31/