# China NMPA Inspection - Qinghai Tongji Pharmaceutical Co., Ltd. - June 20, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qinghai-tongji-pharmaceutical-co-ltd/275678d5-7e53-4844-a096-d1ae8a3df37e/
Source feed: China

> China NMPA unannounced inspection for Qinghai Tongji Pharmaceutical Co., Ltd. published June 20, 2018. An unannounced inspection of Qinghai Tongji Pharmaceutical Co., Ltd., conducted by the Verification Center of the State Food and Drug Administration a

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Qinghai Tongji Pharmaceutical Co., Ltd.
- Company Name: Qinghai Tongji Pharmaceutical Co., Ltd.
- Publication Date: 2018-06-20
- Product Type: Drugs
- Summary: An unannounced inspection of Qinghai Tongji Pharmaceutical Co., Ltd., conducted by the Verification Center of the State Food and Drug Administration as part of a drug inspection plan, revealed significant non-compliance with regulatory standards. The inspection covered company activities from 2016 to 2017, with findings published on June 19, 2018. The primary issues identified pertained to the company's quality control and testing procedures for traditional Chinese medicine decoction pieces. Specifically, the company failed to ensure comprehensive testing of raw medicinal materials. For instance, three batches of purchased wolfberry in August 2016, February 2017, and December 2017 had incomplete commissioned test reports, lacking critical analysis for items such as sulfur dioxide and extractives. Furthermore, one batch of wolfberry (July 2016) and one batch of cordyceps (September 2017) underwent no self-testing or commissioned testing whatsoever. Instead, the company improperly relied solely on supplier test results for finished product release. These deficiencies constituted a violation of the 2010 edition of the "Good Manufacturing Practice for Pharmaceuticals". Consequently, the Qinghai Provincial Food and Drug Administration was directed to revoke Qinghai Tongji Pharmaceutical Co., Ltd.'s relevant GMP certificates. Additionally, the administration was instructed to thoroughly investigate and address the company's illegal and irregular practices in accordance with applicable laws and regulations.

Company: https://www.globalkeysolutions.net/companies/qinghai-tongji-pharmaceutical-co-ltd/d64ebb2f-301b-45fc-8c2e-ac9302490c87/