Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Hello,

I was looking for some guidance on how to notify FDA for facility changes. Some background: For a Contract Manufacturing Facility, changes are proposed to bring back a rented space back in the facility, with no plans for manufacturing or packaging in that area. The space would only be used for storage of retention samples. NDA holders will be notified of this change. Does the CMO need to notify this change in facility to FDA directly or the NDA holder reports it during annual reporting? Also to note that the address of the facility remains the same.

Please advise.

Thank you!

Notification to all approved regulatory application holders listing your facility in their applications should be notified. Direct notification to the FDA district office - not necessary.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 21-Aug-2018 16:58
From: Anonymous Member
Subject: Guidance on notifying FDA with facility changes

This message was posted by a user wishing to remain anonymous

​​Hello,

I was looking for some guidance on how to notify FDA for facility changes. Some background: For a Contract Manufacturing Facility, changes are proposed to bring back a rented space back in the facility, with no plans for manufacturing or packaging in that area. The space would only be used for storage of retention samples. NDA holders will be notified of this change. Does the CMO need to notify this change in facility to FDA directly or the NDA holder reports it during annual reporting? Also to note that the address of the facility remains the same.

Please advise.

Thank you!