Re-packager/Re-Labeler - FDA Registration question

cdmdux

Registered
Hi ,
original UPC barcode Label was created by us. Due to different market channel requirement we have to modify UPC number and barcode. We are not planning to open sealed product. Just over labeling external UPC barcode. Do you see this as a problem?
Nope, that would be within your scope as the legal labeler. Make sure you document it as a nonconformance though (I'm sure you know, but I feel I need to cover myself there)
 

paullarn

Registered
Nope, that would be within your scope as the legal labeler. Make sure you document it as a nonconformance though (I'm sure you know, but I feel I need to cover myself there)
I really appreciate your help and prompt reply. One challenge we have is to explain to our customers why products are over labeled . Some of the big customers are asking us to give them in writing on our company letterhead. They are afraid they may get in trouble for selling "adulterated products". We know these are not "adulterated products" and it is within our scope as legal labeler but I do not want to write a statement which may make sense to a lay person like myself but FDA and/or customer may read it differently.

How do you think we should word it?

I will appreciate if you can give detailed wording with some reference or CFR related to this.
 
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