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…
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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.