Question:

Why does the user receive the error message below when importing a Submission using a .zip file in Vault?

Answer:

This error occurs when the Submissions Record's Application Folder Name field value has other characters added to it other than the 3-letter prefix and 6-digit Application number for the Submission.

The Application Folder Name's field value has to match how the FDA is reviewing the application to avoid issues with cross-document navigation failing in Vault.

An example of how the Application Folder Name field needs to be formatted is shown below:

Related Documentation:

Vault Submission Documentation: Importing Submissions (RIM)