• Home  / 
  • Featured
  •  /  China’s Zhejiang Hisun Pharmaceutical Company Warned

China’s Zhejiang Hisun Pharmaceutical Company Warned

Pharmaceuticals

The U.S. Food and Drug Administration (FDA) has warned a Chinese drug manufacturer called Zhejiang Hisun Pharmaceutical, about its operational conduct. The company works with better-known  ‘big pharma’ names like Pfizer, Sanofi, Merck and Eli Lilly.

The warning relates to serious data integrity violations, apparently occurring over a few months. Such were the FDA concerns, in relation to Good Manufacturing Practice (GMP),  that the Chinese company has been banned from importing its medicines into the U.S.A. for an unspecified time period.

The FDA concerns are spelt out in a warning letter, issued by the Agency. The warning letter highlights excursions from ‘good manufacturing practice’ (GMP, which is the codification of good practices designed to ensure that medicines are safe and efficacious).

Central to the U.S. regulator’s concerns were inadequate laboratory controls designed to ensure that test results, relating to what the drug products contained, were accurate and that changes could not be made by laboratory staff. The FDA was also concerned that re-testing of products in the laboratory had taken place without justification. Some of the re-testing had taken place after data relating to the original tests had been deleted.

The letter went onto note:

“Simply activating audit trail functions and instituting password controls are insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence.”

 

The company has committed to reform its practices, going forwards.

About the author

Tim Sandle

Dr. Tim Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.

  • Victor Grayson

    There seems to be a rise in counterfeit drugs.