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Overseas Drug Manufacturing Takes Another Hit


August 18, 2016

The US Food and Drug Administration (FDA) sent a Chinese drug manufacturing company a warning letter in the wake of an inspection of its facility in Xinchang, Zhejiang.

The FDA pointed out a number of deviations of current good manufacturing practices for Zhejiang Medicine Co. Ltd.

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The warning letter noted that the company: failed to have records with complete data from all tests; failed to prevent unauthorized access or data changes in their computerized systems, as well as data omission; and failed to record activities in real time.

However, the letter was not an all-inclusive list, the FDA noted.

This isn’t the first time a Chinese drug company has been found lacking by the FDA. In February, Pharmacy Learning Network reported that the FDA had banned Zhejiang Hisoar Pharmaceutical’s Taizhou City plant from sending any of its human or animal products to the United States. In December 2015, the FDA warned drug compounders that the baclofen active pharmaceutical ingredient produced by Taizhou Xinyou Pharmaceutical & Chemical Co. could be at risk for containing particulate matter.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory 8/4/16. www.fda.gov. Accessed August 18, 2016.

 

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