reporting errors to the FDA

[scb3363]

After many years as a generalist I have assumed a new role as a supervisor in transfusion services. While getting aquainted with my new environment I have discovered that some previous errors were not reported to the FDA. Being new to this process can anyone provide me some guidance as to how the process of reporting errors to the FDA works (where do I find the necessary paperwork to submit).

thank you

[Cliff]

They prefer you report online.

They are very helpful and very easy to work with. You can contact them at the Support link on that page.

This is also on their site:

If you need assistance you may contact CBER at 301-827-6220 or by email at bp_deviations@cber.fda.gov or hctp_deviations@cber.fda.gov for questions specific to HCT/P deviation reporting.

It looks like a lot more than it really is, but here's the page on reporting BPDR's.

I suspect they'll want you to report the past BPDRs.

[velliott]

Your CSO can help with trying to figure out if something is reportable or not. If they don't know the answer they can point you in the right direction. It might also be good idea to start a dialogue with your CSO. You don't want to put too much attention on the past but having them as a resource can be positive.

[DPruden]

The BPDR guidance is also helpful. They give examples in each category for what is reportable and what is not reportable.

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM062918.pdf