05-10-2023 02:00 PM
Hello,
We have submitted MODIFY and new product publication commands to the GUDID and all items seem to be stuck in the "received" state since Monday. Can someone please check server connections to the FDA?
05-10-2023 02:38 PM
Hello @GustavoA and welcome to the customer community. Thanks for reaching out. Can you confirm whether you are publishing to the FDA in Pre-Prod as part of their certification process or in Production? Id Pre-Prod, it can take them a couple of days to get back to you for the certification process.
05-10-2023 02:42 PM
Hello,
These materials are going to production.
thanks,
gustavo
05-11-2023 10:15 AM
Hello @GustavoA we are taking a look at this for you...
05-11-2023 10:51 AM
Hello Gustavoa,
What modification did you make for the items you sent back to the FDA? We might get a good ETA based on the change.
Thank you!
05-11-2023 10:56 AM
Hello, We did small changes like weights and measures. In addition to this, we sent new material publication commands.
Thanks,
05-11-2023 11:14 AM
Hi Gustavo,
I consulted with our team about the changes. In Production that once a Production GTIN is Synchronized, any updates after that must be done directly in the GUDID portal. You can make the Modify in Item Management, you will also have to go directly into the GUDID to make it the changes on that side.
05-11-2023 11:21 AM
Hello,
Any changes that are executed whether MODIFY commands or new publication requests are never done directly at the GUDID portal. We use a PIM for this activity. Please escalate this case in your support department as soon as possible since this is causing a commercial issue as well a compliance issue for our company.
Regards,
Gustavo
05-11-2023 11:43 AM
Hello @GustavoA . We can see your initial publication to the FDA from yesterday and see the Received status. The CIC comes from FDA. What John was explaining is there are some attributes that you cannot change after the initial publication to FDA and if you need those changed, they require you to do it in their portal rather than republication. Have you been in contact with your FDA contacts as to why they sent Recieved CICs but did not yet send a Synchronized CIC? We are wondering if this is because of abt attribute changes you made post-publication.
05-11-2023 11:52 AM
@GustavoA we are creating a support ticket on our end and will look further with you. Please let me know your thoughts on my previous note.