For Industry

Common Entry Errors

Introduction

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

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

common entry error

Common entry errors found when transmitting data to the FDA

The table below provides information regarding common errors to help you provide accurate and complete information to the 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 the 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 the FDA's 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 the FDA's 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 the FDA about the product and how it is packaged. When the 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 the FDA with the firm 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 the FDA's 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 device initial importer

The device initial importer information provides the FDA with the importer that is further marketing the device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user.  Submitting the incorrect device initial importer could result in either the distribution of products into U.S. commerce that may not meet the FDA's laws and regulations or the shipment being unnecessarily held for additional review.

The device initial importer does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Submitting the incorrect consignee

 

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

 

 

 

Submitting the incorrect value

 

CBP uses the value of the shipment to assess duties, fines and/or penalties; the FDA uses value to determine the 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 ensure 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

 

The 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

 

Incorrect grouping of line items

 

The FDA uses information from each line to determine compliance with the FDA's 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 the FDA laws and regulations.
 

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

 

 

Page Last Updated: 02/27/2019
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