This page addresses any/all known issues and potential resolutions. If you are unable to resolve your issue after reviewing this page, contact support.
Issue: Blank MDN (Acknowledgement)
Transmission is successful but only 1 acknowledgement is sent back and it is blank.
Potential Resolution: Verify Sponsor and Health Authority ID aren’t mismatched. Be sure the Sponsor or Health Authority ID in Veeva RIM is identical to that of the FDA. For example, if your Sponsor ID (DUNS number) is: 12-345-6789 be sure it is that way in the gateway profile and that way on the FDA side. If you have Sponsor ID as 123456789 and the agency has it as 12-345-6789 it could cause this issue to occur.
Issue: FDA sends wrong certificates
The FDA may send the customer several files and it can be a bit confusing which is the proper one to use. With a recent customer, the file was called “AS2 Test certificates” and its file type was “PKCS #7 Certificates”, as shown here, which is the incorrect file type.
Potential Resolution:
Issue: Page Not Found
Page Not Found on the link and username/password sent to the FDA
Potential Resolution: This is the correct screen if the FDA user tries to login and this message is a security protection. The FDA will connect via a different protocol, and will not see this message when sending acknowledgements.
Issue: Dossier Status is stuck at Transmission In Progress
Dossier Status is stuck at Transmission In Progress and never moves to Transmission Successful or Transmission Failed.
Cause: Incorrect Certificate provided by FDA or incorrect certificate/credentials provided to FDA.
Potential Resolution: Confirm the HA Certificate is correct (currently should expire on 15-Jul-2026), Email the FDA ESG Help Desk and confirm the FDA ESG has the correct sponsor certificate and password.
Issue: Not receiving final attachment for ESG Test
Not receiving final attachment for ESG Test in Sandbox Vault.
Cause: FDA ESG Vault account password not set.
Potential Resolution: Ensure a successful login with the FDA ESG Vault account using a set password.
Create the FDA ESG Vault account in your Vault.
You will receive a Welcome to Veeva Vault email to the address specified for the account.
Find the Click here to change your password link and set the non-expiring password.
Log in to Vault with this account to ensure a successful login.
Cause: FDA ESG Vault account password provided to agency was not correct.
Potential Resolution: Email the FDA ESG Help Desk and provide the correct username and password for the Vault FDA ESG account.
Issue: Cannot save FDA ESG Gateway Profile
Cannot save FDA ESG Gateway Profile and receive error message:
“Failed to validate sponsor certificate: Invalid certificate - failed to validate certificate due to wrong password of corrupted file.”
Cause: If you are sure that the password for the certificate is valid (by installing it locally to your machine), it could be that the certificate public key length is too long.
Potential Resolution: The FDA ESG supports certificates with: 1024, 2048, and 3072 public key lengths. The certificate vendor will need to provide a certificate with one of those 3 public key lengths. (Anything larger, such as 4096, will not work.)
For reference, we have seen GlobalSign send customers certificates with the correct public key length and Sectigo has sent certificates that are of length 4096, and therefore, do not work.
To check the public key length, look on the Details tab of the certificate.
Issue: Unable to save the Gateway Profile
Unable to save the Gateway Profile after editing (UI seems to freeze).
Cause: This is a known issue due to the current permission for the Vault Admin account.
Potential Resolution: Contact the Global Service Center (GSC) and provide GSC with the Gateway Profile details. A Veeva Basics Product Owner with a Veeva Admin account will update the Gateway Profile and activate it on your behalf.