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FDA May Refuse Imports of Chinese Drug Manuf. for CGMP, Labeling, Registration Violations

The Food and Drug Administration detailed a laundry list of violations by drug manufacturer Shanghai Huhui Daily Use Chemical Products Co., in a warning letter sent Nov. 14. Specific violations included violations of current good manufacturing practice regulations, and misbranded…

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over the counter drugs because of incorrect labeling. The company also offered its products for sale in the U.S. from 2009 to 2012 without registering with FDA. Until all violations have been corrected, FDA may refuse imports from the manufacturer, it said.