Facility registration information

[bbbirder]

A few years ago we moved our FDA registration to "inactive" status, since we no longer do anything that requires us to be registered. At that time, we started using our CLIA number (last several digits) instead.

With the ISBT labeling using the Digi-Trax printer, the print out is "FDA Registration Number #### (our CLIA#)." The words "FDA Registration Number" are hard coded and can't be changed by us.

We don't do much product modification, only pooling, splitting, and thawing.

Do you think this is a problem for us?

Thanks,

Linda Frederick

[heathervaught]

I would e-mail Pat Distler [pat.distler AT iccbba.org] (substitute the AT with an @ sign). She has been very quick to respond to my ISBT questions.

[bbbirder]

Good idea. I have found Pat to be very helpful as well.

Thanks,

LF

[BBK710]

Linda

I am sure many of us in the same position (using CLIA number) would be interested in what you found out. We are also going to use the Digitrax printer and only pool, split and thaw. This seems to be an awful lot of work for the little bit of product modification that we do.

[Lcsmrz]

I vaguely remember reading FDA documents (not sure which ones, though) stating that using the CLIA number is acceptable, if the facility is not registered. The problem would we having the label say it's an FDA registration number, instead of a CLIA number -- unless the FDA considers them equivalent in a non-licensing situation.

Is this a good Matt@FDA question?