FDA May Refuse Chinese Manuf. Haotian's Drugs for No Registration
The Food and Drug Administration posted a warning letter Sept. 4 threatening refusal of admission for Chinese drug manufacturer Zhucheng Haotian Pharm Co., Ltd.’s products because the company has not met registration requirements. According to the warning letter, dated June…
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
11, Haotian did not register its establishment in 2011 or 2012, but has continued to manufacturer, prepare, propagate, compound, or process drugs that were being imported or offered for import into the U.S. during this time. FDA sent a warning letter to the company in October 2011, but said Haotian did not take any action in response to the letter. As a result, FDA may refuse admission of Haotian’s drugs, it said.