Has anyone out there done this records request inspection from the FDA?  Curious how you provided the information and what your experience was if you are willing to share.

Yes!  We just completed the records request.  I felt that they asked for reasonable items.  Nothing over the top.  For example, last two months reagent QC records, last 2 years temp outliers etc.  The biggest hurdle was that the FDA had a hard time opening the encrypted emails we sent.  Our cyber security team was not comfortable with the file share software that the FDA suggested, as they felt it wasn't secure enough.  We sent the emails several different ways through several different types of encryption.  I felt it was fairly painless in comparison the what we are anticipating for CAP virtual inspection.  

Though it's not FDA, this webinar was put out by CAP and may be helpful addressing issues of data security and ways of submitting. 

https://www.cap.org/calendar/virtual-cap-inspections-two-laboratories-shared-perspectives CAP Virtual Inspection Webinar

You must be registered or licensed, yes? 

On 1/15/2021 at 7:28 AM, RKB1988 said:

Yes!  We just completed the records request.  I felt that they asked for reasonable items.  Nothing over the top.  For example, last two months reagent QC records, last 2 years temp outliers etc.  The biggest hurdle was that the FDA had a hard time opening the encrypted emails we sent.  Our cyber security team was not comfortable with the file share software that the FDA suggested, as they felt it wasn't secure enough.  We sent the emails several different ways through several different types of encryption.  I felt it was fairly painless in comparison the what we are anticipating for CAP virtual inspection.  

Agreed, most isn't terrible. I guess he biggest question I have is the emergency release records.  Did you scan 2 years worth of forms?  We have.... a lot. 

For 2.5 (recipient adverse reactions)- did you just list your number of transfusion reactions by category by month?  

Yes, scanning and security is going to be hurdle.  Do you use the sensitivity labels in outlook?

Did they request a lot/any follow up documentation?

 

Good luck with the CAP, I heard they are not fun but it sound like some of that is just working out the process since it is new.  Ours was an on-site inspection so I don't have any advice/words of wisdome.

On 1/15/2021 at 11:02 AM, David Saikin said:

You must be registered or licensed, yes? 

Yes.

I sent in some information last November and haven’t heard anything since. It’s now July 2021. Wondering what’s supposed to happen? Anyone else hear anything?

We are a large registered facility.  We received the request last week, and only have two weeks to comply.  We also have a Donor Center.  We will need all of those two weeks to gather the documents they requested.

There is a lot lost in doing it this way.  I have been directly involved in our department's inspections for over 20 years.  I enjoy interacting with the inspectors, ask a lot of questions, and learn a lot.  I do hope there is an onsite portion to the inspection.

I know this is an old post, but we are about to apply to become registered with the FDA, and I was wondering how long it takes after we submit our application to be notified of approval/registration. 

 

I am FDA registered and did not get a request for any records. Is this a regulatory requirement to do? 

6 minutes ago, ESIZENSKY said:

I am FDA registered and did not get a request for any records. Is this a regulatory requirement to do? 

I suspect you do not need to worry.  They will contact you.

If you're feeling uncomfortable, you can always check in with your CSO.