Troubleshoot FDA Gateway Submissions

Learn how to identify and resolve common FDA Gateway Submission issues.

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Messages and Acknowledgments

After the FDA receives a submission and validates the certificate, the FDA sends a receipt to Vault Safety, known as the Message Delivery Notification (MDN) or ACK1.

When the FDA attempts to unpackage the submission, they send another acknowledgment, known as ACK2. If the FDA cannot unpackage the submission, the ACK2 is generated with an error and will not be processed further.

In FDA messaging, Warning means they could not parse the file and data and Error means they rejected the submission. Both errors and warnings are enclosed in the <parsingerrormessage> tag in the message body.

The Submission record lifecycle state updates to reflect positive or negative FDA acknowledgments.

The following sections list common FDA Gateway issues and suggestions to resolve each issue.

Transmission Size Limits

All Vault Safety E2B transmissions have a maximum total size limit of 100 MB.

Sending Errors

The following table describes issues that can occur when the system attempts to send a submission to the FDA ESG.

Issue Cause Resolution
Incorrect Gateway Profile Configuration The Gateway Profile is inactive. Make the Gateway Profile Active in Business Admin.
WrappedOpenAS2Exception: Connection refused (Connection refused)
The system could not connect to the URL provided in the Gateway Profile. Verify that the correct Health Authority URL is entered in the Gateway Profile
If the URL is correct, check FDA ESG status.

ACK1 Errors

The following table describes issues that the FDA communicates in ACK1 messages.

Issue Cause Resolution
DispositionException: automatic-action/mdn-sent-automatically; processed/error: authentication-failed
The Gateway Profile contains Incorrect private or public certificates. Verify that the correct public and private certificates are configured in the Gateway Profile.
Contact the FDA to ensure the certificates are correct and registered.
HttpResponseException: Not Found
Incorrect trading partner URL used in gateway profile. Verify that the Health Authority URL is correctly entered in the Gateway Profile.
If the URL is correct, check FDA ESG status.

ACK1 Not Received

The following table describes an issue that can prevent Vault Safety from receiving acknowledgements from the FDA.

Issue Cause Resolution
Body of MDN/ACK1 message is empty The Gateway Profile is incorrectly configured or does not exist. Ensure the Submission record is set up with the correct Gateway Profile, Origin, and Destination.
If these settings are correct, verify that the Gateway Profile is correctly configured in Business Admin.

ACK2 Warnings

The following table describes issues that the FDA communicates in ACK2 warning messages.

Issue Cause Resolution
52:19:E: document type does not allow element "ADDITIONALDOCUMENT" here New Info Date is missing. Ensure the New Info Date is specified on the case.
68:15:E: document type does not allow element "SENDERGIVENAME" here Organization information is missing for the Sender User. Edit the Sender User record to specify the Organization.
67:8:E: end tag for "SENDER" which is not finished No Sender User on the transmission record. Select the Sender User for the transmission.
347:37:E: non SGML character number 128 The ICSR contains one or more non-valid characters. The FDA ESG only accepts standard latin characters (ISO 8859-1). Review the ICSR E2B file and ensure that it only contains latin characters.

ACK2 Errors

The following table describes an issue that the FDA communicates in ACK2 error messages.

Issue Cause Resolution
Minimum data set not met Missing required data for an FDA E2B(R2) ICSR. Ensure the attachment meets the Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments.

Unknown Case ACK

The following table describes an issue that can cause an unknown acknowledgement from the FDA.

Issue Cause Resolution
Please note that an error has occurred in sending Unknown Transmission to the FDA ESG for Submission of Unknown Case. The system received an AS2 message that cannot be traced to the correct transmission.
This may be caused by simultaneous submissions with attachments for the same case UID OR uncompleted tasks on a prior submission.
Contact the FDA with the ACK message and correlation ID to determine the appropriate attachment.
Then, add the ACK message to the correct Submission record.

Send a Gateway Transmission
Troubleshoot EMA Gateway Submissions