Top 5 FDA Entry Submission Errors & How to Avoid Them 

Expediting imports of your FDA-regulated products keeps you a step ahead of the competition, with accurate and complete import entry documentation submitted to FDA critical to that success.

So, why are so many importers still making costly errors in advanced shipment documentation and slowing down their shipments when importing food products in the U.S.? Importing is challenging enough without dealing with preventable errors slowing you down.

Here’s a look at the top 5 most-common FDA entry submission errors and how to avoid them. 

FDA Entry Submission Errors Waste Money 

FDA entry submission errors are the bane of an importer’s existence. With an immense amount of required documentation and often confusing product categorizations, the coding and detail required on import entry documentation can be daunting.

The frequency of entry submission errors costs importers time and money. In the event of importing non-shelf-stable products, destruction of the entire shipment may even be required if expediting entry is not facilitated.  

So, what is so challenging about import entry documentation and how can these errors be remedied? 

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CBP and FDA – The U.S. Gatekeepers  

Let's delve into the essential steps and complexities involved in the documentation process for exporting FDA-regulated products to the United States.

FDA-Regulated Products Exported to the U.S.

  • Export of FDA-regulated products into the U.S. requires documentation filed with Customs and Border Protection (CBP).

Entry Submission Components 

  • Entry submission includes a designated Harmonized Tariff Schedule (HTS) identifying the shipped products. 
  • Additional indicators, known as FD flags, alert FDA to the need for documentation screening and review before the shipment’s arrival.

Additional Steps for Food Products 

  • If the FDA-regulated product is food, Prior Notice must be submitted before the food arrives at a U.S. port of entry. 

FDA’s Review Process 

  • FDA electronically scans documentation for completeness and discrepancies. 
  • Flagging of products, suppliers, importers, and countries on an FDA Import Alert, automatic detention, or FDA Red List for additional scrutiny. 
  • Possibility of receiving an FDA Notice of Action. 

Importance of Compliance 

  • FDA entry submission requirements are cumbersome with many opportunities for errors. 
  • Avoiding errors and responding promptly to FDA requests for additional information can expedite shipments through U.S. ports of entry.

The 5 Most Common FDA Entry Submission Errors

Here is a look at the 5 most common FDA entry submission errors and their corrections. 

#1 Incorrect Affirmation of Compliance (AofC) 

One-third of all FDA entry submission documentation errors are made when completing the Affirmation of Compliance (AofC).

The Affirmation of Compliance and their qualifiers confirm that the imported product meets all the legal requirements enabling it to be sold in the U.S. AofCs include codes for the type of product, such as AIN for a Food Additive Identification Number, FCE for a Food Canning Establishment Number, or IFE for food products intended to be exported and not made for sale in the U.S. If additional information beyond the code is required, qualifiers are indicated, as is the case for the AIN and FCE codes, but not for IFE.  

Use of the correct Affirmation of Compliance and qualifiers when indicated will expedite FDA’s initial screen and entry review.

A mismatch of Affirmation of Compliance and qualifiers can be detrimental to an import submission. Detailed information on AofC codes and qualifiers can be found in FDA’s Affirmation of Compliance Quick Reference, with more detail available in FDA’s Affirmations of Compliance for Automated Commercial Environment (ACE) 

#2 Incorrect Manufacturer Information 

When completing your FDA entry submission, the FDA needs to know the site-specific information from where the products for import were manufactured.

They then cross reference that address with facilities that have obtained an FDA Establishment Identifier (FEI) number. All foreign facilities that intend to manufacture products for sale in the U.S. and their supplier facilities must register that facility with FDA and receive an FEI.

Site-specific manufacturer information includes the complete street address where the item was produced, and this address must match that which is found in FDA’s Facility Establishment Identifier Portal searchable database 

Information can also be cross referenced with commodity-specific listings, such as Drug Establishments Current Registration Site; Device Registration & Listing; Blood Establishment Registration and Listing; Human Cell and Tissue Establishment Registration. It is important to note that not all establishments are searchable within the FEI database. Those that contain personally identifiable information, for instance, are excluded from public view. 

Those importing food products must obtain complete manufacturer information directly from the manufacturer. While FDA does maintain a database of Food Facility Registration numbers (which are required of all food manufacturers), those numbers are for the Agency’s internal use only and not publicly available. 

Typos and incomplete manufacturer information are common and avoidable errors in FDA import entry submissions. Check the FEI database to ensure all required information is complete and accurate. 

#3 Incorrect Product Codes  

Product codes are a series of five to seven letters and numbers representing five components, as shown here using product code 16-J-G-C-J01 as an example: 

  • 16 = Industry (such as fishery/seafood) 
  • J = Classification (such as crustacean) 
  • G = Subclass, or the type or container material (such as synthetic plastic) 
  • C = Process indicator code (PIC), which represents the process, storage or dosage of the product (like refrigerated, raw) 
  • J01 = Product category, which identifies the specific product (such as crab) 

Manufacturers designate their own product codes using FDA’s product code builder. Ensuring an accurate match of the product code and line item on the FDA entry submission will expedite screening and entry. FDA provides video tutorials on using their product code builder. 

Free webinar: Importing Food Products into the U.S.

#4 Incorrect Product Quantity 

On an FDA entry submission, the basic format for identifying product quantity of an imported shipment is listing quantity and unit of measure in decreasing package size. These numbers are reflected in pairs. The first pair of numbers describes the largest container and the last pair describes the amount of product in the smallest container.

As an example, a shipment of 500 cases of 24 cans of 12 fluid ounces is reflected as: 

  • Unit 1 = 500 CS (where CS is a valid abbreviation for case) 
  • Unit 2 = 24 CX (where CX is a valid abbreviation for can) 
  • Unit 3 = 12 OZ (where OZ is a valid abbreviation for ounce) 

The FDA and CBP have dictated valid units of measure and corresponding abbreviations in their supplemental guidance for CBP and Trade Automated Interface Requirements. 

Upon product inspection at import entry, the amount of stated product on the import documentation must match that available to inspect.

Any discrepancies will cause the product to be detained until the importer confirms and corrects their quantity documentation. Additionally, import documentation containing unusual or obviously incorrect quantities or measurements will be flagged for further review. 

#5 Incorrect Shipper Information 

The shipper’s information can be confusing, so questions regarding how to list the shipper are best directed by the person handling the customs documentation.  

For the FDA’s purposes, the shipper is defined as the company that owns the products and arranges their carriage. But it isn’t necessarily the company in the location where the products were collected.

The shipper should also not be confused with the carrier/freight forwarder. Oftentimes the shipper required on FDA documentation is the same firm that is found on the freight bill and bill of lading, and is also often the same required by CBP.   

These 5 common FDA entry submission errors delay imported goods from reaching the U.S. marketplace and cost importers and their customers time and money. Documentation challenges are not always easy to rectify.

When FDA and CBP resources still don’t resolve your questions, Certified Group’s regulatory arm, EAS Consulting Group, can help. Contact us for import assistance and U.S. Agent services 

Get Help With A Detained Shipment

Topics: Food & Beverage, FDA Import, DWPE