# China NMPA Drug Inspection - Bazhong Kelun Pharmaceutical Trading Co., Ltd. - dodder

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/bazhong-kelun-pharmaceutical-trading-co-ltd/ea2ac7f2-6992-4736-844b-70347b2ac19d/
Source feed: China

> China NMPA drug inspection for Bazhong Kelun Pharmaceutical Trading Co., Ltd. published February 23, 2017. Drug: dodder. On February 23, 2017, China's State Food and Drug Administration (SFDA) issued Announcement No. 33, detailing findings f

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 33 of 2017 from the State Administration of Traditional Chinese Medicine regarding 23 batches of substandard prepared slices of traditional Chinese medicine.
- Company Name: Bazhong Kelun Pharmaceutical Trading Co., Ltd.
- Publication Date: 2017-02-23
- Drug Name: dodder
- Inspection Finding: 23 batches of Chinese herbal medicine pieces were found to be substandard. The substandard items included appearance, identification, content determination, and acid-insoluble ash and total ash under the inspection items.
- Action Taken: The relevant provincial (autonomous region, municipality) food and drug administrations have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The State Food and Drug Administration has designated the provincial (autonomous region, municipality) food and drug administrations where the production enterprises are located to investigate the illegal acts of producing and selling substandard products 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 make a penalty decision within one month, reporting the penalty results to the State Administration and disclosing them to the public. All penalties should be imposed on the relevant responsible persons.
- Summary: On February 23, 2017, China's State Food and Drug Administration (SFDA) issued Announcement No. 33, detailing findings from inspections of Traditional Chinese Medicine (TCM) decoction pieces. The announcement reported that 23 batches of unqualified TCM decoction pieces, specifically Cuscuta chinensis (dodder seed) and salted Cuscuta chinensis, were identified. These products were manufactured by 22 different companies, including Hainan Shounanshan Ginseng Industry Co., Ltd., Guoyao Lerentang Hebei Pharmaceutical Co., Ltd., and Anhui Wansheng Traditional Chinese Medicine Pieces Co., Ltd.

The primary issues found involved substandard quality related to appearance, identification, content determination, and levels of acid-insoluble ash and total ash. These deficiencies indicate a failure to meet established quality standards for medicinal products.

In response, provincial food and drug administrations initiated control measures such as seizing and sealing the affected products, mandating sales suspension, product recalls, and requiring rectification from the implicated enterprises. The regulatory framework for these actions is based on Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. The SFDA has directed local authorities to investigate the illegal production and sale of these substandard products, issue penalty decisions within one month, report the outcomes, and publicly disclose the penalties, holding responsible individuals accountable. Enterprises have the right to dispute findings, which triggers further investigation.

Company: https://www.globalkeysolutions.net/companies/bazhong-kelun-pharmaceutical-trading-co-ltd/3ba99cef-071f-4c67-aff8-6479209aa9c0/