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  1. Actions & Enforcement

Filer Evaluations

Overview

A large part of the 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 the FDA, such as customs brokers (entry filers) who submit entry information to the FDA on behalf of importers.

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

 

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

A customs broker or entry filer may be an individual, partnership, association, or corporation that submits information to the FDA about a product that is imported. This information includes the manufacturer of the product, country, shipper, and the 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.  The FDA uses this information to evaluate whether the imported product is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

 

What is a filer evaluation?

To determine the quality and accuracy of data that customs brokers (entry filers) are submitting, the FDA conducts periodic filer evaluations.  These evaluations inform the FDA's confidence about the overall performance of the customs brokers (entry filers).  Filer evaluations are conducted by examining entry documents and comparing the information against data submitted by the customs broker (entry filer).  Discrepancies between the entry documents and submitted data not only reduce the FDA's confidence in the filer's ability to submit accurate data to the FDA, but also can result in significant entry processing delays.

 

What can a customs broker (entry filer) expect during a filer evaluation?

The local FDA office will contact the customs broker (entry filer) to schedule a filer evaluation.  The FDA will ask the customs broker (entry filer) to prepare entry documents for randomly selected entry lines that will be reviewed during the evaluation.

During the evaluation, the FDA compares data submitted by the customs broker (entry filer) with entry documents (e.g. invoice, bill of lading, or other supporting documents).  The FDA will review both required and optional data elements to determine the accuracy of data submission.  Disclaimed lines are also reviewed to determine if the product should have been submitted by the customs broker (entry filer) to the FDA. 

Filer evaluations are classified based on the significance of the errors found.  The significance of an error is assessed by how it affects the FDA's ability to make an appropriate admissibility decision.  In addition, errors that continue to occur after the customs broker (entry filer) has been notified, may increase the significance of the error.

When the evaluation is completed, the FDA will discuss the findings with the top management official.  Once the filer evaluation is classified, a letter containing the filer evaluation results (results letter) will be provided to the customs broker (entry filer).

 

How can a customs broker (entry filer) prepare for a filer evaluation?

Prior to the filer evaluation, the FDA will send a notification letter to the customs broker (entry filer).  The customs broker (entry filer) should follow the instructions in the notification letter.  Customs brokers (entry filers) should maintain documents on each shipment and make them available when requested for a filer evaluation.   

 

How often does FDA conduct filer evaluations?

The frequency for scheduling filer evaluations depends on the type of evaluation being conducted.

  • Routine filer evaluations are conducted periodically and are based on risk as well as resources.
  • Follow-up filer evaluations occur after a customs broker (entry filer) receives an Official Action Indicated (OAI) classification on the previous evaluation. Follow-up evaluations are conducted within 30-45 business days after the FDA receives a corrective action plan (CAP).
  • For-cause filer evaluations are conducted for new or inactive filers or when other situations arise that would warrant an expedited evaluation.

 

Where can I find the outcome of the FDA filer evaluations?

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

Customs brokers (entry filers) are listed alphabetically, along with the evaluation date, filer code, address, and the evaluation outcome.

In September 2018, the FDA updated how filer evaluations are classified (Table 1).  Evaluation outcomes prior to September 2018 (Table 2) will remain until all customs brokers (entry filers) are re-evaluated.  The possible evaluation outcomes are explained in the tables below.

Table 1. Current Filer Evaluation Outcomes

Evaluation Outcome Evaluation Classification  Explanation 
NAI - Acceptable level of confidence No Action Indicated The evaluation resulted in no significant errors providing the FDA with acceptable level of confidence in the data submitted by the customs broker (entry filer).
VAI - Acceptable level of confidence Voluntary Action Indicated The evaluation identified errors, but at this time the FDA has an acceptable level of confidence in the data submitted by the customs broker (entry filer).  The firm should implement corrective actions.
VWR - VAI with Referral - Acceptable level of confidence Voluntary Action Indicated The evaluation identified errors found on remotely filed entries and will be referred to the appropriate import division where the remote filer is physically located. At this time the FDA has an acceptable level of confidence in the data submitted by the customs broker (entry filer). The firm should implement corrective actions.
OAI - CAP 1:  Unacceptable level of confidence (40% manual review) Official Action Indicated The evaluation identified significant errors resulting in an OAI classification.  The FDA does not have confidence in the data submitted by the customs broker (entry filer) and requests that they submit a CAP.  As a result, forty percent (40%) of the entry lines will be held for the customs broker (entry filers) that are classified as OAI-CAP 1.
OAI - CAP 2:  Unacceptable level of confidence (60% manual review) Official Action Indicated The customs broker (entry filer) failed to submit the CAP as requested in the OAI-CAP 1 status and a second CAP request was sent to the customs broker (entry filer).  The FDA continues to have an unacceptable level of confidence in the data submitted by the customs broker (entry filer).  As a result, sixty percent (60%) of the entry lines will be held for the customs brokers (entry filers) that are classified as OAI-CAP 2.
OAI - CAP 3:  Unacceptable level of confidence (100% manual review) Official Action Indicated The customs broker (entry filer) failed to submit the CAP as requested in the OAI-CAP 1 and OAI-CAP 2, and a third CAP request was sent to the customs broker (entry filer).  The FDA continues to have an unacceptable level of confidence in the data submitted by the customs broker (entry filer).  As a result, one hundred percent (100%) of the entry lines will be held for the customs brokers (entry filers) that are classified as OAI-CAP 3.
Inactive Not Applicable The most recent evaluation determined that the firm is either out of business or is no longer filing FDA-regulated entries.

Table 2. Filer Evaluation Outcomes Prior to September 2018

Status Evaluation Result  Explanation 
Paperless Satisfactory Evaluation The FDA has determined that electronic filing is appropriate.
Corrective Action Plan Failed Evaluation Based on the entry filer’s error rate, the FDA has determined that continued electronic filing is appropriate, but the FDA has requested a corrective action plan. The customs broker (entry filer) will be re-evaluated after the corrective action plan has been implemented.
Dual-Mode Filer Failed Evaluation The customs broker (entry filer) has been returned to dual mode (electronic and paper submissions) after the FDA found repeated failures to successfully execute a corrective action plan for improving the quality of the data being submitted.
New Filer Not Applicable The FDA has insufficient information to determine whether electronic filing alone is sufficient; The 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.

 

What happens when a filer evaluation is classified as OAI?

If significant errors are found, a filer evaluation could be classified as OAI.  The FDA will request that the customs broker (entry filer) provide a CAP.  Additionally, a percentage of the entry lines submitted by the customs broker (entry filer) will be held for manual review by the FDA.  The percentage of entry lines held depends on the status of the customs broker (entry filer) as outlined in Table 1 above.  The FDA will re-evaluate the customs broker (entry filer) after the CAP has been implemented.

If the FDA continues to lack confidence in the ability of the customs broker (entry filer) to submit accurate data, the FDA will consult with Customs and Border Protection (CBP).

 

What is a corrective action plan (CAP)?

A CAP is a written plan created by the customs broker (entry filer) management to address the findings identified during a filer evaluation.  The CAP should include how the customs broker (entry filer) will improve their data submission to an acceptable level of confidence. 

 
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