Site Move - Question about Updating Product Labels

#1
Hello, We manufacture is class II pre-amendment In-vitro reagent. We are moving our manufacturing location, and are planning the necessary labeling changes to reflect. My question is; do we have to do anything with our existing finished goods inventory labeling? Thanks for feedback and/or pointing me to a publication that discusses this topic.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Hello, We manufacture is class II pre-amendment In-vitro reagent. We are moving our manufacturing location, and are planning the necessary labeling changes to reflect. My question is; do we have to do anything with our existing finished goods inventory labeling? Thanks for feedback and/or pointing me to a publication that discusses this topic.
Hi, welcome to the Cove.
Since you say "Class II Pre Amendment" I'm going to assume USA and FDA.
By "labeling" are you referring to all labeling (container, carton, IFU, etc. per the FDA definition of Labeling) or just the label on the container?
 
#3
Hello

Thanks for the response. Yes to FDA/USA and specific to the inventory question, the outer container label, and the individual items packaged within. All have the current manufacturing location detail.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Here's a older post on the subject... I agree with what Somashekar and the others say.

Address change on Medical Device labeling

I would not re-label. That can cause even more problems. The address on the label as current at time of manufacture. An advisory notice to customers will fill in any blanks.
 

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