# China NMPA Inspection - Gansu Dadeli Pharmaceutical Co., Ltd. - April 18, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/gansu-dadeli-pharmaceutical-co-ltd/93e8d191-da1c-41de-b078-76293debe491/
Source feed: China

> China NMPA unannounced inspection for Gansu Dadeli Pharmaceutical Co., Ltd. published April 18, 2016. An unannounced inspection of Gansu Dadeli Pharmaceutical Co., Ltd., conducted by the National Food and Drug Administration Center for Food and Drug In

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Gansu Dadeli Pharmaceutical Co., Ltd.
- Company Name: Gansu Dadeli Pharmaceutical Co., Ltd.
- Publication Date: 2016-04-18
- Product Type: Drugs
- Summary: An unannounced inspection of Gansu Dadeli Pharmaceutical Co., Ltd., conducted by the National Food and Drug Administration Center for Food and Drug Inspection from September 23-25, 2015, revealed significant deficiencies in the company's compliance with Good Manufacturing Practice (GMP) for Pharmaceuticals (2010 Revision), particularly concerning its thymopeptide product manufacturing. Key issues identified included a lack of robust quality assurance for raw materials. The company failed to adequately specify the breed, source, age, rearing environment, transportation, or storage of calf thymus, nor did it verify animal quarantine certificates, posing high quality risks. Production management was also found to be insufficient, lacking critical virus inactivation/removal and thermal denaturation validation for multi-component biochemical drugs. Furthermore, process time limits for various production steps were not established. Regarding quality management, the inspection highlighted inadequate internal quality control standards for thymopeptide solutions, which omitted essential safety control items like bacterial endotoxins or pyrogens. Methodological validation for the content, activity, and yield of active components was not performed, and deviation management was ineffective, with an empty deviation log. As a result of these serious non-compliances, the State Food and Drug Administration (SFDA) instructed the Gansu Provincial Food and Drug Administration to revoke Gansu Dadeli Pharmaceutical Co., Ltd.'s GMP Certificate. The company was also ordered to recall all marketed thymosin products and initiate a comprehensive investigation.

Company: https://www.globalkeysolutions.net/companies/gansu-dadeli-pharmaceutical-co-ltd/6519f1da-b669-406d-a42f-0e96fe3faad2/