# China NMPA Inspection - Datong Yungang Pharmaceutical Co., Ltd. - June 07, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/datong-yungang-pharmaceutical-co-ltd/0dd53542-f251-48fb-ad18-8e7e42ff7caf/
Source feed: China

> China NMPA unannounced inspection for Datong Yungang Pharmaceutical Co., Ltd. published June 07, 2016. An unannounced inspection of Datong Yungang Pharmaceutical Co., Ltd. was conducted by the National Food and Drug Administration's Food and Drug Inspec

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Datong Yungang Pharmaceutical Co., Ltd.
- Company Name: Datong Yungang Pharmaceutical Co., Ltd.
- Publication Date: 2016-06-07
- Product Type: Drugs
- Summary: An unannounced inspection of Datong Yungang Pharmaceutical Co., Ltd. was conducted by the National Food and Drug Administration's Food and Drug Inspection and Testing Center from April 23 to 25, 2016. The inspection revealed serious deficiencies in the company's adherence to the Good Manufacturing Practice for Pharmaceuticals (2010 Revision).

Key violations included significant issues with data integrity, where inspection records were found to be untrue. This involved suspected fabrication of analytical spectra and test data for various drug batches, and discrepancies in raw material tracking records, indicating fabricated sampling and purchasing information.

Furthermore, the company's quality assurance system was deemed ineffective. Problems included an unreasonable organizational structure within quality management, unclear responsibilities among personnel, and inadequate control over document management, with critical process specifications being unapproved or uncontrolled. There was also a notable failure to conduct required quality reviews for Dibazol Tablets.

Finally, the inspection identified a complete absence of necessary process validation for Dibazol Tablets and a failure to implement effective validation for computerized systems, as required by regulations.

As a result of these serious findings, the State Food and Drug Administration mandated the Shanxi Provincial Food and Drug Administration to revoke Datong Yungang Pharmaceutical Co., Ltd.'s GMP certificate for tablets. The company is also required to conduct a thorough risk assessment for Dibazol Tablets and implement prompt risk control measures.

Company: https://www.globalkeysolutions.net/companies/datong-yungang-pharmaceutical-co-ltd/6fda8789-78f5-41ae-bc10-020cf3cd9232/