For Industry

Common Entry Errors

Introduction

Timely, accurate, and complete information is important when submitting an import entry to FDA for review. Providing timely, accurate, and complete information will expedite the admissibility decision process for both FDA and the import community.

The following chart shows the most common errors during a one month period of time. These errors had to be manually corrected by FDA prior to review, which delays the review or your entry.

This is a pie chart with common entry error types. It provides each error type and also the percentage of times that particular error occurs. These errors correspond to descriptions in the table below

Common entry errors found when transmitting data to FDA

The table below provides additional information regarding common errors to help you provide accurate and complete information to FDA.

ErrorDescription and ImpactAdditional Information

Submitting the incorrect Affirmation of Compliance (AofC) Information

The AofC information affirms the product meets requirements specific to the product being imported. Submitting the wrong AofC information can delay initial screening and review of an entry.

For more information, see the Affirmation of Compliance Codes page

Submitting the Incorrect Manufacturer Information The FDA Manufacturer information provides FDA with site-specific location where the product is made, produced, or grown. The FDA requirement may be different than the CBP requirement for manufacturer information.  Submitting the incorrect manufacturer could result in either the distribution of products into U.S. commerce that may not meet FDA laws and regulations or the shipment being unnecessarily held for additional review. For assistance, see the FDA Product Code Tutorial, Lesson 2.  
Submitting the Incorrect Product Code The FDA requires a product code to help identify the product. An error in even one element of the product code could result in either the distribution of products into U.S. commerce that may not meet FDA laws and regulations or the shipment being unnecessarily held for additional review. For assistance, see the Product Codes and Product Code Builder page. 
Submitting the Incorrect Quantity 

Quantity data provides additional information to FDA about the product and how it is packaged. When FDA conducts examinations of imported shipments, we check to ensure the quantity submitted is available for exam. Missing product can result in delayed shipments and potential demand for redelivery by CBP.

The basic format for quantity data is in multiple pairs of data – quantity and unit of measure in decreasing package size, i.e., 500 cases, 24 cans, 12 fluid ounces, etc. Up to 6 data pairs may be submitted.

For assistance, see Lesson 2 of the FDA Product Code tutorial 

 

Submitting the Incorrect Shipper Information

 

The shipper information provides FDA with the entity that is shipping the product. Submitting the incorrect shipper could result in either the distribution of products into U.S. commerce that may not meet FDA laws and regulations or the shipment being unnecessarily held for additional review.

 

The shipper can be determined from documents such as the freight bill, bill of lading, etc. The FDA Shipper is usually the same as required by CBP.

 

Submitting the Incorrect Consignee

 

The FDA uses consignee information to determine where in the U.S. the product is going.   FDA requires the consignee to be located in the U.S. Submitting incorrect consignee information could result in FDA communicating with an inappropriate party. 

 

This data field is only required when the consignee transmitted to CBP is not a U.S. firm.

 

Submitting the Incorrect Country of Origin

 

FDA uses the country of origin to determine the origin of the FDA-regulated product.  Submitting the incorrect country of origin could result in either the distribution of products into U.S. commerce that may not meet FDA laws and regulations or the shipment being unnecessarily held for additional review.
Below are a few examples:

  • Peppers are grown in Israel on multiple farms and sent to the Netherlands for packaging.  The country of origin is Israel.
  • Shrimp is caught, peeled, and deveined in Malaysia and exported to Canada.  The Canadian firm incorporates the shrimp into a shrimp dish, such as "Shrimp Quiche." The product is no longer identifiable as shrimp but as "Quiche." The quiche is a product of Canada.
  • ABC Co. in Japan manufactures stereo systems, which contain a CD player manufactured by XYZ Corp. in Korea.

    CBP considers Japan to be the country of origin – based on ABC Co. manufacturing the stereo system.

    FDA only regulates the CD player and considers the country of origin to be Korea, where the CD player was manufactured.
 

CBP considers it to be the country where the product last underwent a "substantial transformation" (resulting in an increase in value). Country of Origin for FDA sometimes differs from CBP.

 

Submitting the Incorrect Value

 

CBP uses the value of the shipment to assess duties, fines and/or penalties; FDA uses value to determine FDA’s reimbursement for compliant samples. Submitting the incorrect value could result in inappropriate fines, penalties, and payment for samples.

 

The FDA value must be submitted in U.S. dollars and cannot exceed the value of the CBP entry. To insure the CBP line/entry value is not exceeded, it is permissible to decrease the FDA line value to make the required adjustment. Such line value adjustments should be recorded on the invoice.

 

Submitting the Incorrect Container Dimensions

 

FDA uses container dimensions to determine compliance with approved submission for Low Acid and Acidified Canned Food Products.
Failure to supply correct dimensions can result in delayed review because the filed process would not match the submitted dimensions.

 

If the container is rectangular, pouch, or irregularly shaped, the dimensions are in the order of width, height, and length.

If the container is cylindrical, the dimensions are in the order of diameter and height.

Measurements are in inches and sixteenths of an inch. For example, a can which is 2 1/2 inches in diameter would equal 2 inches and 8/16ths of an inch, which then translates to 208. 

For assistance, please see the Container Dimension Conversion Chart

 

Submitting the Incorrect Importer

 

The FDA uses the importer information to determine the individual responsible for assuring that imported goods are in compliance with all laws affecting the importation. Submitting incorrect importer information could result in FDA communicating with an inappropriate party.

 

While the importer may authorize others to carry out certain tasks such as filing, the importer of record holds the bond and is ultimately responsible for the entry.

 

Incorrect or Lack of Prior Notice submitted on Foods

 

Prior notice is notification to the FDA that an article of food is being imported into the United States in advance of the arrival of the product at the U.S. border. Failure to submit correct prior notice may result in your entry being held at the port of entry by CBP and FDA.

 

For more information, visit the Guidance for Industry on Prior Notice.

 

Incorrect Grouping of Line Items

 

FDA uses information from each line to determine compliance with FDA laws and regulations.  Entries containing multiple products should be split into different lines wherever a data element is different from product to product.
For example:

  • Products from the same manufacturer but with different FDA Product Codes should be split into separate lines.
  • Products with the same FDA Product Code but from different manufacturers should also be split into different entry lines.
Incorrect grouping or combining of lines may require a new entry submission, can result in delayed review, and could cause products to be released into commerce that do not meet FDA laws and regulations.
 

For assistance, see the Product Codes and Product Code Builder page.

 

 

Page Last Updated: 10/25/2017
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