This message was posted by a user wishing to remain anonymous
Not really but you should be concerned about your internal systems which caused this error and you should investigate this incident and should document all the corrections made to your process so it doesn't happen again! If this was an approved marketed product then its a different ball game!
Original Message:
Sent: 07-Oct-2021 17:16
From: Anonymous Member
Subject: Labelling and shipping error
This message was posted by a user wishing to remain anonymous
Hi all,
Do you need to notify FDA about the shipping of the wrong product/imp to the clinical trial site if no patient was dosed with the wrong product?