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Pharmaceuticals / Inspections and Audits

FDA and EMA Hit Zhejiang Huahai Over GMP Violations

Oct. 2, 2018

The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products.

The EMA issued the statement of noncompliance after an inspection of the company’s Chuannan site in Linhai, China, revealed GMP violations.

The agency issued a recall of products made with the API in July following the discovery of N-Nitrosodimethylamine (NDMA) in the active substance, and it is currently assessing the levels of impurities, possible effect on patients and ways to reduce or eliminate the impure batches.

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