It’s Not Just FDA You Have to Watch out for…

Sep 18, 2014 | China, Drugs, Food, Imports, Medical Devices

fda-inspection-china-approved

Chinese companies exporting foods, drugs or medical devices to the USA: be aware!  FDAImports.com has recently learned China’s FDA inspections include verifying the U.S. FDA registrations of Chinese manufacturers. China FDA is not just verifying companies have valid FDA registrations and product listings, but actually verifying all the details are correct!

It is critically important to file your FDA facility registration, drug listings, and medical device listings with U.S. FDA.  Manufacturers and exporters of foods, drugs, or medical devices must have valid FDA food, drug, or medical device establishment registrations. Drug and device manufacturers and exporters must also submit correct, individual drug or device listings. Foreign drug and device companies that export to the USA must also identify the U.S. importers of their FDA-regulated products!

Companies that are not FDA-registered or who have not listed their drugs and devices with FDA will face regulatory review by the U.S. FDA and China FDA. It is critical to get it right.  FDAImports.com performs facility registrations and product listings daily; if you need to register with FDA or verify your information is correct, contact us to make the process smooth and efficient.

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