FDA Inspections

[butlermom]

We are about to become the blood bank (and laboratory) for another hospital that is being built across the street from us, but is not part of our "system." Because of this we are going to register with the FDA. The other hospital will be storing a few O negative packed cells from us in an under counter refrigerator in their ER. My question is: When we get inspected, will the FDA need to go see their refrigerator? The reason I ask is that I am beginning the process of registration, but don't want to do it too early and have an inspection before the other hospital is open for business. Do I wait until closer to their opening to submit my application, or will the FDA likely not want to go see their fridge with my 2 or 3 units of blood in it?

Thanks for any feedback!

Kathryn

[Bet'naSBB]

I could be wrong on this.....but I don't think the FDA would go to the other facility..........  We have several "sister facilities" that we send blood to for storage that are in our system and another facility that is not in our system.  When we get inspected, they don't go there.....  We are FDA registered because we irradiate and wash/deglycerolize units....ie - "create" products.  I think they just have to comply with CAP and or AABB standards for storage.

[SBBSue]

34 minutes ago, Bet'naSBB said:

I could be wrong on this.....but I don't think the FDA would go to the other facility..........  We have several "sister facilities" that we send blood to for storage that are in our system and another facility that is not in our system.  When we get inspected, they don't go there.....  We are FDA registered because we irradiate and wash/deglycerolize units....ie - "create" products.  I think they just have to comply with CAP and or AABB standards for storage.

Agreed, we also supply blood to a facility outside our system, and the FDA inspector did not visit their facility.

[John C. Staley]

If you will be getting any of those units back then a FDA inspector may want to see their storage records.  Some will, some won't, depends on the inspector.  Better to be prepared for the one that wants to see them.  In this case a little paranoia may be a good thing.

[SBBSue]

On 9/22/2023 at 11:05 AM, John C. Staley said:

If you will be getting any of those units back then a FDA inspector may want to see their storage records.  Some will, some won't, depends on the inspector.  Better to be prepared for the one that wants to see them.  In this case a little paranoia may be a good thing.

Good tip!  We use temp indicators on the units, so that when they are returned, we can see if the unit was out of temp at any point.  We also asked them to provide a packing slip attesting to the proper storage of the units, similar to a transfer form used by our blood suppliers.  

[butlermom]

We have not had our inspection yet. I’m wondering is there a checklist for the FDA somewhere that we might review to know how to prepare? Decades ago at another FDA registered facility I don’t recall ever having a checklist. 

[Cliff]

On 4/20/2024 at 1:56 PM, butlermom said:

We have not had our inspection yet. I’m wondering is there a checklist for the FDA somewhere that we might review to know how to prepare? Decades ago at another FDA registered facility I don’t recall ever having a checklist. 

I've been through many FDA inspections, and while they do have general guidelines of what they look at, I've never seen a checklist. 

You might want to take a look at this:

https://www.pathlabtalk.com/forum/index.php?/blogs/entry/22-inspections/

[John C. Staley]

If I remember correctly most of my FDA inspectors carried around the CFR Title 21 and did most of their inspection while constantly referring to it, primarily those sections referring to blood bank but sometimes they were looking at other sections as well.  It's been too long for me to remember the specific sections.   I went through CFR21 and highlighted the areas I thought were most important and prepared for them.  I actually had one FDA inspector who was a SBB and knew what they were talking about.    She did our inspection so we could get a license to ship blood products interstate.  That was the best inspection I ever had in 30 years of supervising blood banks.