# China NMPA Inspection - Changchun Xin'an Pharmaceutical Co., Ltd. - March 15, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/changchun-xinan-pharmaceutical-co-ltd/eaf178a8-8473-4b46-9991-ecb6751dc3ef/
Source feed: China

> China NMPA unannounced inspection for Changchun Xin'an Pharmaceutical Co., Ltd. published March 15, 2017. An unannounced inspection of Changchun Xin'an Pharmaceutical Co., Ltd. conducted from January 10-12, 2017, by the State Food and Drug Administration a

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changchun Xin'an Pharmaceutical Co., Ltd.
- Company Name: Changchun Xin'an Pharmaceutical Co., Ltd.
- Publication Date: 2017-03-15
- Product Type: Drugs
- Summary: An unannounced inspection of Changchun Xin'an Pharmaceutical Co., Ltd. conducted from January 10-12, 2017, by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration, uncovered severe non-compliance with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). Significant violations included the unauthorized alteration of the production process for Yankening tablets, specifically the direct use of raw Phellodendron bark powder instead of the legally prescribed extraction method, coupled with extensive fabrication of batch production records dating back to 2015.

The quality control laboratory demonstrated chaotic management, including widespread falsification of inspection records, failure to conduct required raw material inspections, lack of complete inspection requests, reports, original analytical data, and the backdating of inspection reports to reflect testing from 2015 that was performed in 2017. Instrument management was inadequate, lacking proper access controls, hierarchical management, and essential data backup, compromising data integrity and traceability. Furthermore, the company failed to retain required product and raw material samples and lacked complete commissioned test reports.

Production management issues included uncleaned, moldy equipment, the absence of process validation for Yankening tablets since the implementation of new GMP, and insufficient infrastructure for extraction processes. Material management was also deficient, characterized by inconsistent inventory records, falsified sampling documentation, inadequate material identification, and expired supplier quality agreements. Company leadership, including quality and production managers, failed to effectively fulfill their oversight and quality veto responsibilities.

Consequently, the regulatory authorities ordered the revocation of Changchun Xin'an Pharmaceutical Co., Ltd.'s GMP certificate, mandated the immediate recall of all problematic products, and initiated a formal investigation into the findings.

Company: https://www.globalkeysolutions.net/companies/changchun-xinan-pharmaceutical-co-ltd/f5d9d9fd-39a7-40dd-a7b7-7a7c72eb5205/