(FDA spokesman corrects information to show import ban only applies to a single Huahai factory. FDA’s original statement on its website remains unchanged)
By Alexandra Harney and Michael Erman
SHANGHAI/NEW YORK, Sept 28 (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 at China’s Zhejiang Huahai Pharmaceuticals Chuannan factory, 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.
European authorities also said on Friday that they had found that Huahai did not comply with good manufacturing practices and that the company’s factory in the Chuannan province, was no longer authorized to produce valsartan.
The European Medicines Agency said it was considering further action for other substances produced at the site.
On Sept. 28, the FDA posted a statement on its website that said: “The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States.”
On Oct. 10, FDA spokesman Jeremy Kahn said that the statement was incorrect, and the import ban only applies to the Chuannan factory. As of Oct. 10, the incorrect statement was still on the FDA’s website.
The FDA said it was halting imports from the plant after it found major manufacturing process issues during its 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 from the Chuannan plant.
FDA spokesman Jeremy Kahn said the agency had no concern about additional drug shortages due to the import ban at this time.
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 by 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.”
Regulators and industry consultants say the NDMA was most likely introduced when Huahai changed the way it made valsartan in 2012. The FDA’s Kahn told Reuters in an email in August that the change in valsartan manufacturing that was believed to have led to the introduction of NDMA occurred around December 2013.
Reporting by Michael Erman in New York and Alexandra Harney in Shanghai, Additional reporting by Ben Hirschler in London and the Shanghai newsroom; editing by Chizu Nomiyama and Bill Berkrot