Hi - need help / opinions please.
Discussion going on here - situation is
A specific size label is used in production - printed on zebra printers and then applied to packaging. Found out the adhesive on the label stock contains latex. We have not claimed latex on the label.
There are some that feel that "since the label doesn't come into contact with the patient we are fine using it".
My thought
/suggestion is that we need to:
1. Order new labels without latex.
2. Dispose of the latex roll labels.
3. While using what is in stock until new labels (without latex) are received, we must state the type of latex on the label.
Am I not interpreting 21CFR 810.437 accurately?
Thanks in advance for your many words of expertise!
Discussion going on here - situation is
A specific size label is used in production - printed on zebra printers and then applied to packaging. Found out the adhesive on the label stock contains latex. We have not claimed latex on the label.
There are some that feel that "since the label doesn't come into contact with the patient we are fine using it".
My thought
1. Order new labels without latex.
2. Dispose of the latex roll labels.
3. While using what is in stock until new labels (without latex) are received, we must state the type of latex on the label.
Am I not interpreting 21CFR 810.437 accurately?
Thanks in advance for your many words of expertise!

