For Industry

Filer Evaluations

Overview

A large part of FDA’s consumer protection oversight of imported products is dependent on the entry process. The entry process is reliant upon data provided by parties outside of FDA, such as customs brokers (entry filers) who submit entry information to FDA on behalf of importers.

The purpose of FDA’s Filer Evaluation Program is to inform FDA’s confidence in the entry data received from brokers (entry filers).

Back to top

What or who is a customs broker (entry filer)?

A customs broker or entry filer may be an individual, partnership, association, or corporation that transmits information to FDA about a product that is imported. This information includes the manufacturer of the product, country of origin, shipper, and FDA product code. It also could include more technical information, such as manufacturers registration number, product listing number, premarket approval, or any other requirement specific to the product.  FDA uses this information to evaluate whether the imported product is in compliance with the Food, Drug, and Cosmetic Act.

Back to top

What is a filer evaluation?

In order to inform FDA regarding the quality and accuracy of data that entry filers submit, the agency conducts periodic filer evaluations.  The frequency of evaluations varies, depending on the number of lines submitted during the previous 12 months and the entry filer’s evaluation history.  Filer evaluations not only inform FDA about overall performance of the entry filer but also provides an opportunity to provide feedback to the entry filer. 

An entry filer who fails an evaluation is requested to draft a corrective action plan.  Once corrective actions have been implemented, the entry filer will be re-evaluated.  Entry filers who fail the re-evaluation may be required to submit both electronic and paper files.

Back to top

I am an entry filer. What can I expect during my filer evaluation?

The local FDA office will contact you to schedule a filer evaluation and to request entry documents to review for randomly selected entries.

During the evaluation, the FDA filer evaluator will compare the data electronically transmitted to FDA with the entry documents, such as an invoice or bill of lading.  The evaluation will cover all data elements transmitted to FDA which includes both required and optional data elements that were transmitted. For required and optional data, please see the Tips for Importing FDA-Regulate Products in ACE or the FDA Supplemental Guidance for ACE/ITDS.

FDA will also review disclaimed lines during the evaluation.  If the product was disclaimed and it is an FDA-regulated product, it will be considered an error.  If a product was appropriately disclaimed—meaning the entry filer correctly claimed that the product is not FDA-regulated--it is not considered an error.

Back to top

I am an entry filer.  What can I do to prepare for a filer evaluation?

The entry filer should assure all data submitted electronically is accurate.  Entry filers should maintain documents on each shipment and make them available when requested for a filer evaluation. 

Back to top

How often does FDA conduct filer evaluations?

The frequency for scheduling filer evaluations depends on the number of lines filed by a firm.  Depending on the volume of lines filed, the frequency ranges from semi-annually to once every four years.

Back to top

Where can I find the outcome of FDA filer evaluations?

FDA filer evaluation outcomes are available to the public.  They are posted on line and can be found in the document FDA Filer Evaluation Outcomes.  The list is updated monthly and gives the most recent outcome for each entry filer.  Because this list is prospective, and updated monthly, interested parties should not make any inferences with regard to the status of entry filers who do not have filer evaluation outcomes posted on this site.

Entry filers are listed alphabetically, with one of five possible outcomes explained in the table below.

Table 1. Filer Evaluation Outcome Explanations

Status Evaluation Result  Explanation 
Paperless Satisfactory Evaluation FDA has determined that electronic filing is appropriate.
Corrective Action Plan Failed Evaluation Based on the entry filer’s error rate, FDA has determined that continued electronic filing is appropriate, but FDA has requested a corrective action plan. The entry filer will be re-evaluated after the corrective action plan has been implemented.
Dual-Mode Filer Failed Evaluation The entry 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 Not Applicable FDA has insufficient information to determine whether electronic filing alone is sufficient; FDA requires both electronic and paper submissions.
Inactive Not Applicable The most recent evaluation determined that the firm is either out of business or is no longer filing FDA-regulated entries.

Back to top

Does FDA distinguish between minor and significant errors?

The current filer evaluation process does not distinguish between minor and significant errors. However, FDA is working to develop a new filer evaluation process, which will take the significance of errors into account.

Back to top

What happens if an entry filer fails an evaluation?

If the entry filer fails an evaluation, FDA requests that they provide a corrective action plan. FDA will re-evaluate the entry filer after the corrective action plan has been implemented.  

If FDA continues to lack confidence in the entry filers ability to transmit accurate data,  FDA will consult with Customs and Border Protection (CBP). 

Back to top

Page Last Updated: 08/03/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English