Hello,
I recently came across 2 CAPA Folders that were for recalls in 2022. We use our CAPA process to track all documents associated with the recall. The CAPA's were completed, Recall Status Reports were done according to 21CFR Part 7 and the CAPA was closed. Our recalls are not for our product, we are a kit packer and the recalls are for supplier medical devices within the kit that were recalled. Kits are never returned because everything else in the kit is acceptable to use.
So my question to The Cove is, the Recall Termination Letter was never sent. Is there a time frame for submitting a Recall Termination Letter to the FDA?
I have the terminatin letter ready to go, is there anything specific I should say when I submit it?
Thanks in advance for any advice.
Maryvicki
I recently came across 2 CAPA Folders that were for recalls in 2022. We use our CAPA process to track all documents associated with the recall. The CAPA's were completed, Recall Status Reports were done according to 21CFR Part 7 and the CAPA was closed. Our recalls are not for our product, we are a kit packer and the recalls are for supplier medical devices within the kit that were recalled. Kits are never returned because everything else in the kit is acceptable to use.
So my question to The Cove is, the Recall Termination Letter was never sent. Is there a time frame for submitting a Recall Termination Letter to the FDA?
I have the terminatin letter ready to go, is there anything specific I should say when I submit it?
Thanks in advance for any advice.
Maryvicki
