Establishment Inspection Report - Request

S

sabrina.qa

Does anyone have advice on the most straightforward way to request an EIR? We're trying to register medical products for sale in South America that another company manufactures, and they only received their 483s it seems. The inspection is from 2013.

I'm not interested in making a request under FOIA, since this is the company itself asking for the EIR. (Although I'll do it if that's the only recourse!) I'm not sure how to advise them to request it, however. My first inclination was to go to FURLS but the FDA has nothing addressing that there.

Thanks for any input!
 
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