# China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Yankening tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-pharmaceutical-co-ltd/afb37fef-664a-48b8-a643-03758c81e3e5/
Source feed: China

> China NMPA drug inspection for Sichuan Pharmaceutical Co., Ltd. published January 19, 2017. Drug: Yankening tablets. The State Administration for Market Regulation (now National Medical Products Administration) issued Announcement No. 10

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 10 of 2017 from the State Administration for Market Regulation regarding 16 batches of substandard drugs.
- Company Name: Sichuan Pharmaceutical Co., Ltd.
- Publication Date: 2017-01-19
- Drug Name: Yankening tablets
- Inspection Finding: The drugs were found to be substandard. The substandard items included appearance, content determination, and specific tests such as bacterial count, fill volume variation, dissolution time, related substances, and weight variation.
- Action Taken: Control measures such as sealing and seizing have been taken, requiring the company to suspend sales and use of the products and recall them; the provincial (autonomous region, municipality) food and drug administration where the production company is located has been ordered to investigate and handle the matter according to law; and the production company has been ordered to thoroughly investigate the cause and make complete rectifications.
- Summary: The State Administration for Market Regulation (now National Medical Products Administration) issued Announcement No. 10 of 2017 on January 19, 2017, disclosing that 16 batches of drugs from 11 pharmaceutical companies were found to be substandard. Companies involved included Shanxi Kangwei Pharmaceutical Co., Ltd., Shandong Kongshengtang Pharmaceutical Co., Ltd., Chengdu Di'ao Group Tianfu Pharmaceutical Co., Ltd., and several others.
The primary issues identified across various drug batches involved deviations in critical quality attributes. These violations encompassed appearance defects, inaccurate content determination, elevated bacterial counts, inconsistencies in fill weight and overall weight variation, and failures in dissolution time and related substances tests. These findings indicate non-compliance with established quality control standards for pharmaceutical products.
In response to these findings, the State Food and Drug Administration mandated provincial food and drug administrations to implement immediate control measures. These actions included sealing and seizing the affected products, ordering companies to cease sales and usage, and initiating product recalls. Furthermore, the regulatory framework, specifically the "Drug Administration Law of the People's Republic of China," requires investigations into the non-compliant manufacturers. These companies are compelled to conduct thorough investigations into the root causes of the deficiencies, implement comprehensive rectifications, and publicly disclose relevant information. This comprehensive regulatory response aims to ensure drug quality and public safety.

Company: https://www.globalkeysolutions.net/companies/sichuan-pharmaceutical-co-ltd/73053b74-f673-40ef-ae8b-f01e72e92784/