FDA Warns China API Maker for Hiding Quality Testing Data

Source: South China Morning Post

Aug 17, 2016

The U.S. FDA says Zhejiang Medicine hid quality testing results that may have indicated product contamination.

According to a recent FDA warning letter based off of findings from a June 2015 inspection of Zhejiang Medicine's Xinchang Pharmaceutical Factory, the drugmaker performed unofficial tests and then did not consider the results when evaluating API quality. Some of these unofficial tests displayed large unknown peaks that were not reported in the official records for the same samples.The firm also backdated worksheets for impurity tests by several days, according to the letter.

Zhejiang Medicine has a contract that ends next year to supply Pfizer’s Hospira unit with the main ingredient for vancomycin, a widely used antibiotic. According to a Pfizer spokesperson, the company hasn’t seen any issue with the products supplied by Zheijiang Medicine.

Read the South China Morning Post coverage

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