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U.S. Department of Health and Human Services

Import Refusal Report
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Structure of the Import Refusal Data Files

There are three sets of zip files. Each one contains the Refusals for a group of years. Currently:

  • Fiscal Year 2002 through 2006
  • Fiscal Year 2007 through 2010
  • Fiscal Year 2011 to date.

If using Excel to view the CSV files, Excel 2007 or later is required

In order to keep the file sizes manageable the violation codes and translations are in a separate file ACT_SECTION_CHARGES.CSV. This will also be refreshed monthly. Since the charge code is not unique there is a unique numerical identifier (asc_id) associated with the charge code and appropriate translation. Each zip file will contain an identical copy of the ACT_SECTION_CHARGES.CSV file.


The act section charges data files have the following structure:

ASC_ID   CHRG_CODE   CHRG_STMNT_TEXT   SCTN_NAME  
258   FLAVR LBLG-258 The article appears to contain an artificial flavoring and it fails to bear labeling stating that fact. 403(k), 801(a)(3); MISBRANDING
260   FALSE-260 The labeling appears to be false and misleading in any particular. 403(a)(1), 801(a)(3);
262   DIETARY-262 The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation. 403(j), 801(a)(3); MISBRANDING

The asc_id’s can be linked back to the refusal charges in the refusal data.



The refusal data files have the following structure:

1. MFG_FIRM_FEI_NUM    
2. LGL_NAME   Name of the Declared Manufacturer
3. LINE1_ADRS   Manufacturer Address
4. LINE2_ADRS   Manufacturer Address
5. CITY_NAME Manufacturer City
6. PROVINCE_STATE   Manufacturer Province or State
7. ISO_CNTRY_CODE   2 Letter ISO country code
8. PRODUCT_CODE   5-7 Character product code
9. IMP_DESCRIPTION   Importers or Corrected Description
10. REFUSAL_DATE    
11. DISTRICT   FDA District where entry was made
12. ENTRY_NUM   CBP Entry Number
13. RFRNC_DOC_ID   CBP Line Number
14. LINE_NUM   FDA Line number
15. LINE_SFX_ID   FDA Line Suffix
16. FDA_SAMPLE_ANALYSIS   Y if there are FDA Analytical Results
17. PRIVATE_LAB_ANALYSIS   Y if there was a Private Lab package
18. REFUSAL_CHARGES   asc_id’s (1 to many) of the charges for which product was refused. If there are multiple they will be separated by a comma e.g. 320, 328, 321, 482, 218, 3320

This can be used to link to the charge codes & Charge statements in the ACT_SECTION_CHARGES.CSV file.
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