# China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - pepsin granules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-pharmaceutical-co-ltd/7db5126c-36fc-4c13-98d3-bf5c6a57b4cb/
Source feed: China

> China NMPA drug inspection for Sichuan Pharmaceutical Co., Ltd. published December 22, 2017. Drug: pepsin granules. On December 22, 2017, the State Food and Drug Administration (SFDA) of China, now the National Medical Products Administ

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration for Market Regulation Announcement No. 220 of 2017 Regarding 9 Batches of Substandard Drugs
- Company Name: Sichuan Pharmaceutical Co., Ltd.
- Publication Date: 2017-12-22
- Drug Name: pepsin granules
- Inspection Finding: Content volume difference is unacceptable
- 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. These departments will also investigate the illegal activities and publicly disclose the results within a specified timeframe.
- Summary: On December 22, 2017, the State Food and Drug Administration (SFDA) of China, now the National Medical Products Administration (NMPA), issued an announcement (No. 220 of 2017) regarding nine batches of substandard drugs from three manufacturers. This regulatory action followed testing by institutions including the Gansu Provincial Institute for Drug Control, which identified significant quality deficiencies. The companies implicated were Hebei Jinxing Pharmaceutical Factory, Guizhou Yibai Pharmaceutical Co., Ltd., and Sichuan Shunsheng Pharmaceutical Co., Ltd. Hebei Jinxing's Compound Pancreatin Powder (multiple batches from 2016-2017) failed microbial limit tests. Guizhou Yibai's Pepsin Granules (2016 batches) were found to be substandard in potency assays. Similarly, Sichuan Shunsheng's Pepsin Granules (batch 161004) exhibited issues with content weight variation. In response, provincial food and drug administrations implemented immediate control measures, including sealing, seizing, suspending sales, and recalling the affected products. Under the authority of Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, the SFDA mandated further investigations into the illegal activities of these companies. The provincial authorities were required to publicly disclose the outcomes of their investigations and punitive actions within three months, and to report findings to the SFDA. This underscores China's commitment to upholding drug quality and patient safety through rigorous regulatory oversight.

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