FDA corrects previous word on embattled valsartan maker's ban

After Zhejiang Huahai Pharmaceutical’s tainted valsartan API triggered a global recall, the FDA slapped an import ban on the drugmaker. But the agency made a confusing mistake in announcing the move—a mistake it just corrected.

The FDA announced Sept. 28 that it had imposed an import alert banning "all" active pharmaceutical ingredients made by Huahai, and finished drug products made using Huahai’s APIs, from entering the U.S. But the actual import alert on the FDA website appeared to be directed only to the Chinese pharma’s Chuannan site in the city of Taizhou, China.

The ban has taken a toll on the company's Shanghai shares. Every day this week, the stock hit the 10% maximum daily drop allowed. Huahai is also facing multiple lawsuits over the tainted valsartan in Missouri, New Jersey, Illinois and New York, with allegations including gross negligence, fraudulent concealment, breach of contract and unjust enrichment.

Tuesday, the FDA confirmed that the import alert only applies to the Chuannan site, but had yet to change the wording in its original statement by publication time.

The ban came after FDA officials turned up shortcomings in the company’s manufacturing process at Chuannan during an inspection from July 23 to Aug. 3. As laid out in an 11-oberservation Form 483, the FDA lambasted the company for making process changes without conducting proper risk assessments.

In a recent disclosure to the Shanghai Stock Exchange, the company depicted the import ban as a complete surprise. According to the company, the FDA had been trying to arrange a reinspection of the site in December or January, only to cancel on Sept. 28 as it published the import alert.

The FDA declined to comment on the change of mind as it "does not publicly discuss information regarding potential inspection plans," the agency told FiercePharma.

Huahai caught the FDA and European regulators’ attention after a suspected cancer-causing agent called N-nitrosodimethylamine was detected in its valsartan API. The agency and Huahai had attributed the impurity to a manufacturing process change the company made years ago.

After a global recall and an inspection by the Italian Medicines Agency, the European Medicines Agency issued its own embargo—on its supply of valsartan API to the EU.

Huahai said the products banned by the FDA and EMA accounted for 11.24% of its 2017 sales. All of the company’s valsartan API is made at its Chuannan site, but it makes other APIs at its Xunqiao site. The same facility also makes all of the company’s finished drugs exported to the U.S. The Xunqiao site was previously dinged by the FDA during an inspection in 2016, but the FDA later cleared it in 2017.

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