EU, US Ban Manufacturer use of Valsartan From China’s Zhejiang Huahai

Regulatory NewsRegulatory News | 28 September 2018 |  By 

The European Medicines Agency (EMA) issued a statement of noncompliance to a Zhejiang Huahai valsartan manufacturing site in China while the US Food and Drug Administration (FDA) placed it on import alert Friday in their ongoing investigations into probable human carcinogens.
The actions are part of an international effort among regulatory authorities to address the drug safety issue that led to recalls of medicines containing valsartan produced in bulk by Zhejiang Huahai. EMA was the first to initiate a recall of the valsartan products in July over the detected presence of the impurity N-nitrosodimethylamine (NDMA), followed by FDA and Health Canada.
EMA, FDA and Health Canada reported earlier this month a second impurity classified as a probable human carcinogen—N-nitrosodiethylamine (NDEA)—had been detected in products containing the company’s valsartan active substance.
EMA’s statement of noncompliance to the plant in Linhai, China comes after an inspection on the manufacturing of valsartan “found several weaknesses at Zhejiang Huahai, including deficiencies in the way the company investigated the presence” of both of the detected impurities, the regulatory authority said. “This means that marketing authorization holders in the EU are prohibited from using valsartan from the site for the production of medicine.”
EMA suspended the company’s certificate of suitability for the supply of valsartan in the EU, along with that of another China-based company that has also been associated with the drug safety issue, Zhejiang Tianyu Pharmaceuticals, just last month.
Last week, EMA announced it extended its review of the two detected impurities to include four additional “sartans” after traces of NDEA were detected in the losartan products manufactured by Hetero Labs in India. The other three sartans are candesartan, irbesartan and olmesartan.
FDA’s import alert temporarily prohibits all active pharmaceutical ingredients manufactured by Zhejiang Huahai from legally entering the US until the company determines how impurities came to be present in its products and implements quality system remediation actions.
The move follows an FDA visit to the site in Linhai in July and August that resulted in a Form 483 citing a total of 11 inspectional observations, including underreported product deviations. 
“FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes,” the agency said. “If a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.”


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