Product labeling for modified products...FDA registration/license #'s

[suhu]

When a new component label is applied to a product our blood bank modifies, for example an irradiated red cell or an aliquot preparation, what FDA registration number and/or US license number is required to be on the product label?  The new component label we apply has our FDA registration number, but is it required to redact the supplier's FDA registration number and/or license number? 

[MERRYPATH]

We scratch out the US license number when we attach a new label...our component label is a computer generated half label applied over the bottom half of the original product label. That half label has our Processed By: information with our FDA regustration number. We do not scratch out the original FDA Registration Number for the original supplier just the License number. In days gone by we had a separate sticket for each part as we relabelled components.

[Lbiggs]

What is the requirement for relabeling a pediatric syringe aliquot?

[carolyn swickard]

MERRYPATH - which FDA Registration number do you put on your labels - the FEI number or the CFN number?  I have even asked the FDA inspectors which to use and have not received an answer.  Can you tell me?  Thanks

[Linda0623]

In our practice, we ensure BOTH facilities information are on the final label. We collect blood, but do not irradiate on site. So if I need our blood supplier to irradiate a unit that we have collected, our LIS allows us to make the component and enter the modifying facility's ICCBBA/FDA information in the bottom right quadrant of the label, and it is linked in the audit trail of the modification of the product. It also adds the statement "Further Processing By:" preceding the FDA license/registration information. Because we are the collecting facility to which the DIN and collection /FDA registration information is linked, I would think we would be mismatching the origin of the collection if we were to scratch out the information attached to the collecting facility.

 

For cswickard----we use our FEI number as the registration number on our labels, and have had no issue during FDA inspections---and our irradiated labelling has been evaluated by them successfully as well.

Hope this helps!

[carolyn swickard]

Thanks Linda for the info.

 

When we first started irradiating units here, we were taught by the Irradiator company (by way of a cooperating Blood Center) how to label the modified units and we line out the UBS FDA license number on our units too.  We have had several inspections and the FDA has never corrected us.  The reasoning sems to be that whoever modifies the unit "owns" responsibility for the unit since they have performed a modification on the unit that can affect the "safety, purity or potency" of the product.  Your operation of your facility drawing the unit first and then asking a distributor to irradiate it, may fall in a different category altogether.

[Linda0623]

I believe it does, because we actually had the FDA approve our process with the Blood Supplier doing the irradiation before they started performing the task for us :-)----because they do not enter the product into their inventory as a distributable product, only as modified, we retain the responsibility of tracking through final disposition.