FDA Tells Chinese Drug Manufacturer It Needs to Register, Properly List Drugs

The Food and Drug Administration has told a Chinese pharmaceutical company that it has not fulfilled its registration obligations under the Federal Food, Drug, and Cosmetic Act, according to a warning letter posted Aug. 14 on FDA’s website.

Companies are required to submit registration information annually by electronic means for each foreign establishment owned or operated that manufactures, prepares, propagates, compounds, or processes a drug that is imported or offered for import into the United States, the agency said. Drugs also may not be imported unless they are properly listed.

FDA said the company, Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co., ...