Cargo Systems Messaging Service

CSMS #49059465 - FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub-Reason Code

On September 4, 2021 the U.S. Food and Drug Administration (FDA) will deploy the following:

• A validation to check the syntax of the email transmitted in PG21 for the FSV entity. If a valid FSV email syntax is not transmitted, the entry will be rejected. (Related: CSMS #48912861)

• A validation to allow only one Product Code Qualifier and one Product Code Number in PG02for a given FDA line. If an FDA line is received with multiple Product Code Qualifiers and/or multiple Product Code Numbers, the entry will be rejected. (Related: CSMS #46970234)

• Implementation of new sub-reason 187 (SECOND AND FINAL REQUEST FOR INFORMATION) under reason code 25 (ADDITIONAL VERIFICATION NEEDED). The new sub-reason 187 will be sent to filers with an open document request that exceeds 72 hours from the initial request for documents. Filers or importers are encouraged to submit documents via ITACS in order to prevent this additional SO message. This change will be applied to all current open document requests older than 72 hours. (Related: CSMS #47756187)

For further assistance on this deployment or FDA ACE technical inquiries, contact FDA ACE Support, 877-345-1101, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8AM-8PM ET.

Related messages: CSMS #48912861, CSMS #46970234, CSMS #47756187