# China NMPA Inspection - Sichuan Xieli Pharmaceutical Co., Ltd. - January 18, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/sichuan-xieli-pharmaceutical-co-ltd/8dd31a0e-0e53-4c27-a5e7-9cf324813a0d/
Source feed: China

> China NMPA unannounced inspection for Sichuan Xieli Pharmaceutical Co., Ltd. published January 18, 2019. During an unannounced inspection conducted from July 16-19, 2018, Sichuan Xieli Pharmaceutical Co., Ltd. was found to be in violation of the Good Manu

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of the Results of the Surprise Inspection and Handling of Sichuan Xieli Pharmaceutical Co., Ltd.
- Company Name: Sichuan Xieli Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-18
- Product Type: Drugs
- Summary: During an unannounced inspection conducted from July 16-19, 2018, Sichuan Xieli Pharmaceutical Co., Ltd. was found to be in violation of the Good Manufacturing Practice for Pharmaceuticals (revised in 2010). The inspection, performed by regulatory authorities, revealed several critical issues. A primary concern was the production and sale of berberine hydrochloride before the company had obtained the necessary pharmaceutical GMP certificate for those specific workshops. Several batches were produced and sold between May and June 2017, prior to the certificate being issued in September 2017. Furthermore, the annual quality review for berberine hydrochloride was deficient, lacking critical analysis of the production environment and equipment, and failing to investigate significant fluctuations in impurity and moisture content. The company also demonstrated inadequate quality control for purchased key starting materials, specifically crude berberine hydrochloride, which came from various suppliers without proper quality assurance agreements detailing source or process. Lastly, product process validation was insufficient, with only three out of seven batches of berberine hydrochloride undergoing validation. As a consequence of these findings, the Sichuan Provincial Drug Administration ordered the company to rectify the issues, supervised the recall of potentially unsafe products, and ultimately revoked the company's relevant GMP certificates in July 2018.

Company: https://www.globalkeysolutions.net/companies/sichuan-xieli-pharmaceutical-co-ltd/64e9f81e-df4a-4e16-9107-9e60664a05b6/