# China NMPA Inspection - Changchun Yuanda Guoao Pharmaceutical Co., Ltd. - October 23, 2014

Source: https://www.globalkeysolutions.net/records/china_inspection/changchun-yuanda-guoao-pharmaceutical-co-ltd/278c10d4-1849-44f7-8684-5f94feeb9390/
Source feed: China

> China NMPA unannounced inspection for Changchun Yuanda Guoao Pharmaceutical Co., Ltd. published October 23, 2014. An unannounced inspection conducted by the State Drug Administration (now National Medical Products Administration - NMPA) on August 23-24, 2014, reve

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on the on-site inspection of Changchun Yuanda Guoao Pharmaceutical Co., Ltd.
- Company Name: Changchun Yuanda Guoao Pharmaceutical Co., Ltd.
- Publication Date: 2014-10-23
- Product Type: drugs
- Summary: An unannounced inspection conducted by the State Drug Administration (now National Medical Products Administration - NMPA) on August 23-24, 2014, revealed significant regulatory violations at Changchun Yuanda Guoao Pharmaceutical Co., Ltd. The inspection focused on the company's production practices, particularly for its Guanxin Danshen Capsules. Key findings included suspected non-compliance with prescribed ingredient formulations, specifically the alleged use of Panax notoginseng powder instead of the raw Panax notoginseng, and the incorporation of unextracted Danshen medicinal materials. Furthermore, the company was found to have incomplete audit processes for its medicinal material suppliers. These issues collectively indicated a serious deviation from the fundamental requirements of Good Manufacturing Practice (GMP) for pharmaceutical products. In response to these grave findings, the Jilin Provincial Drug Administration took decisive action, revoking Changchun Yuanda Guoao Pharmaceutical Co., Ltd.'s "Drug GMP Certificate." An official investigation into the matter has been launched. Cases where criminal activity is suspected have been referred to the public security authorities for appropriate legal proceedings. The situation remains under active and further investigation by the relevant authorities.

Company: https://www.globalkeysolutions.net/companies/changchun-yuanda-guoao-pharmaceutical-co-ltd/89e59a24-b4d0-450c-b573-560f468fec43/