Pragmatics Lite Validator

The Pragmatic Validator Lite Tool is a great resource to utilize to detect technical errors in your SPL R4 documents. However, the validator is NOT connected to the FDA database and therefore will not detect ALL SPL R4 Errors. Listed in the attached PDF document are some of the validation errors that the Pragmatic Data Validator Lite tool will not detect.

FDA Reminder: Before submitting SPL files

Please ensure that all of the data provided in SPL files submitted to register drug establishments and list drug products is accurate.
1. Ensure that application numbers are accurate and that the numbers are not transposed.
2. Check the addresses in your Establishment Registration SPL documents to ascertain that the information is correct
3. Remember that SPL authors now determine the date which the listing SPL documents can be released to the public. Check the marketing start date to ensure that you agree that the listing SPL file can be released on that date.

Common Errors

eBook Link

Dec 2009

Here is a list of common technical errors in SPL R4 documents received since the electronic drug establishment registration and drug listing pilot commenced on July 10, 2008, to November 2009:
  1. Missing folder - Place each SPL document and any associated image file(s) in a folder and upload the folder containing the SPL and image files via the FDA Gateway’s "OC" directory.
  2. Extra folder layers - Send SPL file and associated image files in a single folder with no subfolders.
  3. Incorrect or missing file extension – The file extension for SPL documents is ".xml" (lower case letters only) and the file extension for image files is ".jpg" (lower case letters only) .
  4. Incorrect file format – Winzip (zipped files) Excel, PDF, Word, and eCTD files are not acceptable formats for documents submitted for the purpose of electronically registering a drug establishment, submitting or requesting a NDC labeler code, or listing a drug product via the FDA OC Gateway. Only XML and JPEG (jpg) file formats are acceptable.
  5. Submitting more than one XML file per folder – Only one SPL file should be included in each folder.
  6. Incorrect SPL file name – Use the SPL document ID with the file extension ".xml"
  7. Extraneous text in Product Names – Remove dosage form, route of administration etc. from the product name(s) in the product data elements section of the SPL document
  8. Submitting same NDC labeler code in a different SPL with a different setID - Don't include labeler code in more than one Labeler Code request.
  9. Submitting DUNS number in more than one Establishment Registration file - Don't include DUNS number for registration in more than one Establishment Registration file.
  10. Mismatched DUNS numbers - Ensure that the DUNS Number and address for a drug establishment matches the DUNS number, postal code and country in the Dun and Bradstreet database.
  11. Invalid e-mail address - remove spaces before or after e-mail address.
  12. Inclusion of an application or citation number on products that don't have these - Only products with codes C73583, C73584, C73585, C73588, C73603, C73604, C73605, C75302, C80438, C80440, C80441, C80442 should have application or citation numbers in the SPL.
  13. Not enough sections in content of labeling - With the exception of bulk ingredient and medical gas product SPL documents, include each section of the content of labeling in the appropriate SPL content or labeling section.
  14. Incorrect UNII name - Use the preferred name and UNII from the UNII list.
  15. Missing Principal Display Panel - Include each representative sample of a carton/container label in a major SPL section with section heading "Package.Label Principal Display Panel.
  16. Incorrect version number - The value of the version number must be greater than the value of any previously submitted version for the same setID>
  17. Image file too large - Reduce the size of each image file to less than 1MB

    Additional notes:

    Common Errors Presentation