TrackWise Digital FDA Gateway delay in FDA responses to ACK3.

Incident Report for Honeywell

Resolved

FDA ACK3 response patterns have returned to normal.
Posted Sep 02, 2025 - 16:27 EDT

Monitoring

We’ll continue to monitor all outstanding ACK3 to ensure submissions are handled appropriately.
Posted Sep 02, 2025 - 11:34 EDT

Investigating

We’ve observed a delay in FDA responses to ACK3 notifications between August 30 and August 31. As of September 2 at 9:00 AM EST, ACK3s are being received and processed. We’ll continue to monitor all outstanding items closely to ensure submissions are handled appropriately.
Posted Sep 02, 2025 - 11:27 EDT
This incident affected: US Region - Production Environment (TrackWise Digital FDA Gateway).
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