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U.S. Department of Health and Human Services

For Industry

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Import Filer Evaluation Outcomes

Importers, or third parties working on behalf of importers, file information about products offered for import into the United States.  FDA conducts evaluations of those filers who submit information electronically to help ensure that they are submitting accurate data. 

FDA is posting filer evaluation outcomes on-line, prospectively, starting from the beginning of FY2012, to help increase the accuracy of the information submitted to FDA and the accountability among the actors in the supply chain.  This list will be updated monthly, and it will post the most recent outcome for each filer.   

Because this list is prospective, and updated monthly, interested parties should not make any inferences with regard to the status of filers that do not have filer evaluation outcomes posted on this site.

FDA recognizes that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and FDA is working to improve this process.  In general, FDA attempts to re-evaluate filers with excessive error rates within nine months, as volume and resource constraints permit.  FDA is exploring procedures that would speed up this re-evaluation, which would provide an incentive for filers to improve their outcomes quickly. 

The following files list filers alphabetically, and it discloses one of five different outcomes for each filer:

•    Paperless – Satisfactory evaluation result; FDA has determined that electronic filing is appropriate.

•    Corrective Action Plan – Based on the filer’s error rate, FDA has determined that continued electronic filing is appropriate, but FDA has requested a corrective action plan.

•    Dual-Mode Filer – The filer has been returned to Dual Mode (electronic and paper submissions) after FDA found repeated failures to successfully execute a Corrective Action Plan for improving the quality of the data being submitted.

•    New Filer – FDA has insufficient information to determine whether electronic filing, alone, is sufficient; FDA requires both electronic and paper submissions.

•    Inactive – The most recent evaluation determined that the firm is either out of business or inactive in FDA commodities.