5 Easy Facts About FDA US Agent Described
5 Easy Facts About FDA US Agent Described
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if FDA is unable to contact the foreign institution instantly or expeditiously, FDA may perhaps offer info or documents into the U.S. agent, and these types of an motion shall be looked upon as akin to offering a similar info or files to your foreign establishment.
The U.S. agent are not able to use just an answering service. They must be accessible to respond to the telephone or have an personnel accessible to answer the cellphone all through regular small business several hours.
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Receives correspondence within the FDA to the registration and listing information to the foreign establishment
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S. Agent should be physically situated in America and will serve as the main and/or default position of Call between FDA and also the agency. The responsibilities with the FDA U.S. Agent are outlined in 21 CFR 207.sixty nine as follows: