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The Food and Drug Administration (FDA) continues to receive email addresses with an invalid syntax for the FSV entity. On August 8, 2022, this logic will be tweaked to help ensure FDA receives an email with a valid syntax. Refer to PG21 in FDA’s ACE Supplemental Guide for examples of valid and invalid email addresses. If an invalid syntax is received filers will receive the following status codes and should review the email address transmitted for the FSV entity:
Status Code: 04 Data rejected per PGA review
Reason Code: 14 Data rejected per PGA review
Subreason Code: 197 Invalid format for mandatory email requirement
For questions regarding this reject or FDA ACE technical inquiries, contact FDA ACE Support, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8:00 AM - 8:00 PM.
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