For Industry

CBER Common Entry Errors

Introduction

The Center for Biologics Evaluation and Research (CBER) regulates the following:

  • Biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology.
  • Certain medical devices involved in the collection, processing, testing, screening, manufacture and administration of licensed blood, blood components, and tissue and cellular products
  • HIV test kits used to screen donor blood, blood components, tissue and cellular products (HCT/Ps), and products used to diagnose, treat, and monitor persons with HIV and AIDS.

To expedite entry screening of CBER-regulated products by the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, it is important that importers and entry filers  provide accurate product codes, all relevant affirmations of compliance (AofC), and accurate identifiers for firms, in addition to the general entry data. 

When complete and accurate entry data is supplied electronically, it can be used by the PREDICT system to “look-up” the information in FDA’s databases, validate the information, and issue a system “May Proceed” if the line is not held due to any other screening criteria.

When the entry data provided is not complete and/or accurate, the “look-up” will fail and the entry line may be subject to delays in processing.

Details on applicable product codes and affirmations of compliance are included in the “Additional Information” section at the bottom of this page.

The following chart shows the most common look-up errors for CBER-regulated products during Fiscal Year 2015 (10/1/14 to 9/30/15).

This is an image of two pie charts depicting the Common Biologic Look-up Failures. The first pie chart, titled Common Biologic Look-up Failures - Overall, has two slices and depicts the error of No AofCs provided at 81% of the reasons for errors. The Other slice is 19% and categorized as other. A second pie chart, titled Common Biologic Look-up Failures - Other, is generated from the
 

When the entry data provided is not complete and/or accurate, the entry line may be subject to delays in processing.  The table below provides additional information regarding these common errors to help you provide accurate and complete information to FDA.

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Common Biological Look-up errors that result in a failed Look-up

ErrorDescription Additional Information 
No AofCs provided 

No Affirmations of Compliance (AofC) were provided for this entry. 

If this product is FDA regulated supply the required AofC information. If this product is not FDA regulated and does not require declaration to FDA disclaim future entries.  

For more information see Affirmations of Compliance 
AofCs insufficient for biologic products lookup 

The product was declared as a biologic product (Industry code 57), however, the Affirmations of Compliance (AofC) provided were insufficient to perform the lookup for biologic products. 

Verify the product code and/or AofC code or qualifier.  

For more information see Importing CBER regulated products into the United States 
STN not found or not valid

Submission Tracking Number (STN) transmitted could not be found in FDA's biologic products database, is not valid, or was declared in an improper format. 

Verify correct AofC code and corresponding qualifier.

The qualifier for this affirmation should be a six-digit submission tracking number. Information on the STN numbers can be found from the link below. 

Or the STN could have been transferred to CDER. A complete listing of STNs transferred to CDER is available from the link below.

BLN not found or not valid 

The Biologics License Number (BLN) transmitted could not be found in FDA's biologic products database, is not valid, or was declared in an improper format. 

Verify correct AofC code and corresponding qualifier. 

For more information see the list of licensed establishments and applicable products available
Firm name does not match 

The firm name provided in the entry did not match the firm name on file for the AofC transmitted.

Verify that the firms supplied on the entry match those filed with CBER. 

For more information see Biologics Products & Establishments 
Product does not match 

The product transmitted for the entry did not match the corresponding product for the AofC transmitted.

Verify that the product claimed on the entry matches the product on file with CBER. 

For more information see Biologics Products & Establishments
Licensed product status 

The product status for licensed biologic products must be "Approved." The product status of "Approved" was not found for the declared licensed biologic product. 

Verify that the licensed biologic product has been approved. 

 
IND/IDE found but did not match 

The product status for investigational biologic products must be "Active" or "Exempt".

Verify that the IND has the correct status. The IND may also be transferred to the Center for Drug Evaluation and Research 

The investigational biologic product in the line may be transferred to the Center for Devices and Radiological Health (IDE) or the Center for Drug Evaluation and Research (IND).

For more information see INDs transferred to CDER

IDE/IND not found or not valid 

The Investigational New drug (IND) or Investigational Device Exemption (IDE) transmitted could not be found in FDA's biologic products database, is not valid, or was declared in an improper format.

Verify correct AofC code and corresponding qualifier. 

 
IND not intended for biologic products 

The product was declared as a biologic product (Industry code 57), however, the IND declared is insufficient to perform the biologic product lookup. 

Verify the Industry code and/or the AofC declared. If the IND has been transferred to CDER, use a product code that identifies the product as a drug, not a biologic. 

PMA/PMN/NDA/AND not found or not valid 

New Drug Application (NDA), Abbreviated New Drug Application (AND), Premarket Approval (PMA), or Premarket Notification number (510(K)) transmitted could not be found in FDA's biologic product database, is not valid, or was declared in an improper format.

Verify correct AofC code and corresponding qualifier. 

For more information see Biologics Products & Establishments
PMA/PMN/NDA/AND found but did not match 

New Drug Application (NDA), Abbreviated New Drug Application (AND), Premarket Approval (PMA), or Premarket Notification number (510(K)) transmitted did not match entry data (firm and/or product) transmitted for the entry.

Verify the firms and product listed on the line match what was submitted for the NDA, ANDA, PMA, or PMN. 

For more information see Biologics Products & Establishments
Human Tissue Registration Number (HRN) Not Found or Not valid 

Human tissue registration number (HRN) transmitted could not be found in FDA's biologic product database, was not valid, or was declared in an improper format.

Verify correct AofC code and corresponding qualifier. 

Human Cell and Tissue Establishment Registration Public Query 
HRN found but did not match 

Human tissue registration number (HRN) transmitted did not match entry data (firm and/or product) transmitted for the entry.

Verify the firms and product listed on the line match what was submitted to CBER for the HRN. 

Human Cell and Tissue Establishment Registration Public Query

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Page Last Updated: 10/25/2017
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