FDA Halts Imports From China`s Huahai After Heart Drug Recall

By Alexandra Harney and Michael Erman

SHANGHAI/NEW YORK (Reuters) - The U.S. Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by China's Zhejiang Huahai Pharmaceuticals, after a recall of one of its drugs that contained a probable carcinogen.

The Chinese bulk manufacturer of the high blood pressure treatment valsartan recalled the product from consumers in the United States in July because an impurity linked to cancer had been detected.

The FDA said it was halting imports after it found major manufacturing process issues during a more recent inspection of Huahai's plant. The agency said the freeze on the imports would remain in place until the Chinese manufacturer determines how the impurities were introduced and improves its quality control systems.

Huahai's English-language website suggests that the company makes more than 50 drugs, active pharmaceutical ingredients and intermediate products used in a variety of medicines to treat high blood pressure, depression and other conditions. It was not immediately clear how many were exported to the United States.

In a heavily-redacted inspection report to Huahai posted on the FDA’s website on Sept. 20, the health regulator pointed out a range of serious problems, including with the company’s quality management system, how it evaluates the impact of changes to its manufacturing process, and its handling of products with impurities.

In all, the Aug. 3 report listed 11 problems based on an inspection by two investigators sent to the factory for about two weeks in late July and early August.

Huahai's public relations department could not be reached for comment.

The company, which is based in eastern China's Zhejiang province and makes bulk ingredients for drugmakers, told customers in late June that it had found N-nitrosodimethylamine or NDMA, which is classified as a probable human carcinogen, in its valsartan.

In September, after a global recall of valsartan products, the FDA and the European Medicines Agency announced that another known carcinogen called N-Nitrosodiethylamine, or NDEA, had also been found in valsartan made by Huahai and India's Torrent Pharmaceuticals, another manufacturer.

The FDA often redacts product-specific information in inspection reports, and the report released last week did not mention valsartan, NDMA or NDEA. However, the FDA wrote that Huahai's "change control system to evaluate all changes that may affect the production and control of intermediates or Active Pharmaceutical Ingredients (APIs) is not adequate."

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