# China NMPA Drug Inspection - Beijing Shengshilong Pharmaceutical Co., Ltd. - yam

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/beijing-shengshilong-pharmaceutical-co-ltd/61b713ae-741b-498a-8b1a-6d5d6f957f60/
Source feed: China

> China NMPA drug inspection for Beijing Shengshilong Pharmaceutical Co., Ltd. published June 22, 2018. Drug: yam. The National Medical Products Administration (NMPA) of China issued Announcement No. 46 of 2018 on June 22, 2018, detail

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 46 of 2018 from the National Medical Products Administration regarding 10 batches of drugs that did not meet the requirements.
- Company Name: Beijing Shengshilong Pharmaceutical Co., Ltd.
- Publication Date: 2018-06-22
- Drug Name: yam
- Inspection Finding: Total ash content does not meet regulations
- Action Taken: Relevant drug regulatory authorities have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The National Medical Products Administration has instructed relevant provincial drug regulatory authorities to investigate the aforementioned enterprises and units for illegal activities such as producing and selling counterfeit and substandard drugs in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," and to complete the investigation and handling of the relevant enterprises or units within three months from the date of receiving the inspection report and publicly disclose the results.
- Summary: The National Medical Products Administration (NMPA) of China issued Announcement No. 46 of 2018 on June 22, 2018, detailing non-compliance across 10 batches of drugs from nine different pharmaceutical companies. This announcement followed testing conducted by five provincial drug testing institutions, including the Qinghai Provincial Institute for Food and Drug Control.

Key manufacturers identified for violations include Bozhou Jingwan Traditional Chinese Medicine Pieces Factory, Tonghua Xinghua Pharmaceutical Co., Ltd., Harbin No. 6 Traditional Chinese Medicine Factory Co., Ltd., Yichun Jinbei Pharmaceutical Co., Ltd., Anhui Jiezhong Biochemical Co., Ltd., Sichuan Tianfu Shenlong Traditional Chinese Medicine Pieces Co., Ltd., Jiuquan Peifeng Traditional Chinese Medicine Ecological Planting and Processing Co., Ltd., Yantai Juxian Pharmaceutical Co., Ltd., and Beijing Shengshilong Pharmaceutical Co., Ltd.

The main issues of non-compliance, assessed against the *Pharmacopoeia of the People's Republic of China*, varied by product. These included deficiencies in appearance, content determination, fill weight uniformity, dissolution rate, acid-insoluble ash, and total ash content.

In response, regulatory authorities implemented immediate control measures, such as sealing and seizing the affected drugs. The implicated companies were directed to cease sales and use, recall products, and undertake necessary rectifications. Furthermore, the NMPA mandated provincial drug regulatory authorities to launch investigations into these companies for illegal activities, referencing Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*. These investigations are to be completed within three months, with the findings made public.

Company: https://www.globalkeysolutions.net/companies/beijing-shengshilong-pharmaceutical-co-ltd/abd85ccb-d753-4e45-8550-04fc279f00aa/