Chinese Drugmaker Hid Data That May Show Contamination
- U.S. FDA warns Zhejiang Medicine on data manipulation
- Company has contract with Pfizer unit to provide vancomycin
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A Chinese manufacturer of antibiotics sold in the U.S. hid quality testing results that may have indicated product contamination, the latest evidence of data manipulation at firms that make ingredients used by large pharmaceutical companies.
The U.S. Food and Drug Administration told Zhejiang Medicine Co. to hire a consultant and investigate “the extent of the inaccuracies in data records and reporting” on quality assurance, according to a warning letter dated Aug. 4 that was released Tuesday. The drugmaker was ordered to conduct a “risk assessment of the potential effects of the observed failures,” according to the letter.