FDA Warns Banned Chinese API Maker for Data Manipulation

Source: FDA

Jan 15, 2016

The U.S. FDA has warned China-based Zhejiang Hisun Pharmaceutical for serious data integrity violations a few months after banning the company’s products from entering the U.S.

The warning letter, which references an inspection from from March 2-7, 2015, points to signifcant cGMP violations, including a lack of basic laboratory controls to prevent changes to records, and routine re-testing of samples without justification followed by deleting of analytical data.

While the FDA acknowledged the manufacturer's commitment to improvements, the letter warned that "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."

According to Zhejiang Hisun Pharmaceutical's website, they have worked with Pfizer, Sanofi, Merck and Eli Lilly.

Read the RAPS coverage
Read the FDA Warning Letter

 

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