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U.S. Department of Health and Human Services

For Industry

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Import Refusals

The Food, Drug, and Cosmetic Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. The Inspection Refusal Report (IRR) reports on those products for which a determination was to refuse admission to part or all of the product offered for importation.

The IRR is generated from data collected by FDA's Operational and Administrative System for Import Support (OASIS) and is updated monthly.  

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U.S. Food and Drug Administration Import Refusal Report for OASIS

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