The @WholeChainCom Blog - Pardalis Inc.

Posted to Many Eyes by the Food Safety Information Center:

"The Food, Drug, and Cosmetic Act (the Act) authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. The FDA district office will then issue a "Notice of FDA Action" specifying the nature of the violation to the owner or consignee. The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action" Refusing admission to the product. The product then has to be exported or destroyed within 90 days. The [obsolete] IDR [Import Detention Reports] gave an incomplete picture in that it only reflected the initial action by the Agency and not the ultimate determination of the compliance status of the product. The IRR reports on those products for which the that determination was to refuse admission to the product. The IRR [Import Refusal Reports] is generated from data collected by FDA's Operational and Administrative System for Import Support (OASIS) and is updated monthly. Each month, the IRR is available sorted by country and by product based on the industry code which is the first two characters of FDA's product code (e.g., all fishery/seafood products will be coded 16...). FDA has prepared this information in an effort to provide the importing community with information on products that have been found to appear in violation of the Act." Data Source: Import Refusal Reports for OASIS - US Food and Drug Administration (FDA). [Bracketed language added for clarity]