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US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

 
• By Bowman Cox

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

FDA also trains Chinese regulators and manufacturers on techniques that promote safety. At a workshop in Zhejiang province, FDA’s Daniel Geffin showed Chinese regulators how he inspects equipment used to sterilize canned foods
Zhejiang Huahai warning letter is part of US FDA/industry dialogue that includes this canned food sterilization workshop in China's Zhejiang Province • Source: US FDA

Even though Zhejiang Huahai Pharmaceuticals Co. Ltd., Linhai, China, may have been following “current industry practice,” its failure to anticipate that a manufacturing process change would introduce a carcinogenic impurity into its valsartan active pharmaceutical ingredient in 2012 was inconsistent with current good manufacturing practices, FDA told the firm in a warning letter it posted Dec. 11.

In response to FDA’s Aug. 3 inspection report, the firm on Aug. 26 implored the agency to consider that the...

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