good manufacturing practice- Irradiating in house

[DN8BLUD 0]

Hi all

Am I understanding correctly that Transfusion services require to label there in house irradiated products "Irradiated by...X Hospital"? 

Thank you in advance.

[David Saikin 1,420]

Not only that but you also need to be FDA registered (when you produce a new blood product).

[slsmith 55]

The in house irradiated product label doesn't say "irradiating in house" but it does in the lower right corner of the label have the hospital name and the FDA registration number. Probably the same thing? Anyway my hospital is inspected by FDA, AABB, CAP and ISO; never have we had a issue with this process.

[Joanne P. Scannell 219]

21 hours ago, slsmith said:

The in house irradiated product label doesn't say "irradiating in house" but it does in the lower right corner of the label have the hospital name and the FDA registration number. Probably the same thing? Anyway my hospital is inspected by FDA, AABB, CAP and ISO; never have we had a issue with this process.

Ditto (except for the AABB inspection).  When we thaw, aliquot, and/or irradiate, the default message is 'Further processed by ...' followed by our Facility Name (exactly as our license states), address and FDA License #.  Never been a problem this way.