FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

Posted 29 November 2016 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March.

The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufacturers—linked to the deaths of nearly 150 Americans in 2008—have persisted.

According to FDA, heparin is a widely used anti-coagulant and is commonly used during surgical procedures and for those undergoing dialysis. There are about 12 million Americans who use heparin annually.

This latest warning letter for a China-based heparin manufacturer follows a letter from several members of the House Committee on Energy and Commerce last March with concerns related to FDA delays to the import alerts issued to more than 30 Chinese firms (meaning their products were banned from entering the US, though the list has not been updated since 2014) at the source of the contaminated heparin. 

FDA Warning Letter

The letter, dated 10 November, cites Dongying Tiandong Pharmaceutical Co. Ltd.’s manufacturing facility with four specific deviations from an October 2015 inspection.

“Our investigator found that your firm repeatedly, and without justification, resampled and retested crude heparin batches when your quantitative polymerase chain reaction (Q-PCR) test for ruminant DNA exceeded your established specification limit,” the letter says. “You neither evaluated the initial sample OOS, nor conducted retesting of the initial original sample to confirm it. Instead, you resampled until you obtained a passing result.”

PCR issues and the others are similar to what France’s National Agency for Medicines and Health Products Safety (ANSM) inspectors uncovered in their investigation last March.

But FDA has not banned the company’s products from entering the US, noting, “Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Dongying Tiandong Pharmaceutical Co.”

Warning Letter

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Categories: Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, Asia, FDA

Tags: heparin, warning letter, heparin manufacturers in China

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