FDA Posts Import Filer Evaluation Outcomes Online

The Food and Drug Administration is posting filer evaluation outcomes online, prospectively, starting from the beginning of fiscal year 2012, 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 FDA will post the most recent outcome for each filer. The FDA states that, 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.

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

FDA Attempting to Improve Distinction Between Serious Mistakes & Typos

The FDA states that it recognizes that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and is working to improve this process. In general, the 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.

Alphabetical lists of satisfactory evaluations, corrective action plan requests, repeated failures to execute corrective action plans, new filers, and inactive filers are available here.