Is this scenario a mock product withdrawal or recall?
Hello, I am running a hazard analysis and mock recall scenario for a new situation we are about to embark on. We are going to be using a 3rd party warehouse and distribution center for our RTE cookie dough. We retain ownership until the product is packed and leaves the 3rd party dock for shipping. We are trying to clear our warehouse as soon as possible to allow for production space, but that could possibly mean shipping product to the 3rd party center before lab testing results are in. Would this be under a product withdrawl? Does the FDA need to be notified if the product hasnt made its way to the store yet? I know the recall procedures and such for anything that happens within our facility walls; but im assuming that other parties need to be involved if we are disrupting the chain to voluntarily withdrawal product due to bad test results. I checked the other forums and couldnt find anything specific to this type of scenario. Any guidance would be appreciated
to be clear
you're product until it ships regardless of warehouse (yours or 3rd party)
It would still be in your control, NOT a withdrawl situation
If you are able, ship the product on HOLD in the electronic system so it can't be picked in error and shipped out
When we do that, we ask DC to put that product on hold until QC clear
I agree with the above, it's not a recall/withdrawal until it leaves your control and enters commerce. You might want to have a strong positive release procedure in place which specifically addresses how you want it to be handled at the third party warehouse level.
For example, signs/placards or other identifier (in my facility we use yellow QUALITY HOLD) that remains on product not yet clearing a CoA. This of course is removed and accounted for once you get a passing CoA.
Hello, I am running a hazard analysis and mock recall scenario for a new situation we are about to embark on. We are going to be using a 3rd party warehouse and distribution center for our RTE cookie dough. We retain ownership until the product is packed and leaves the 3rd party dock for shipping. We are trying to clear our warehouse as soon as possible to allow for production space, but that could possibly mean shipping product to the 3rd party center before lab testing results are in. Would this be under a product withdrawl? Does the FDA need to be notified if the product hasnt made its way to the store yet? I know the recall procedures and such for anything that happens within our facility walls; but im assuming that other parties need to be involved if we are disrupting the chain to voluntarily withdrawal product due to bad test results. I checked the other forums and couldnt find anything specific to this type of scenario. Any guidance would be appreciated
The terminology "mock" is rather confusing/questionable.
UK has a quite precise definition of "withdrawal" as compared to "recall" (both involving reported Product defects) but USA I have no idea (?).
Current usage of terminology "withdrawal" seems to be ad-hoc ?.
Offhand, yr proposed manouevring seems sort of innocuous/inoffensive but I suggest to ask the FDA (via website?) if you are really concerned. (i appreciate there may be reluctance to enter the "Lion's den"). :smile:
Although the third party warehouse is technically your internal customer (of the manufacturing department) however the product haven't lost your control because the ERP of that warehouse is not supposed to use that product on their own unlike a finished product delivered to a customer. Therefore it doesn't require to trigger a withdrawal procedure however I would call in a RISK ASSESSMENT GROUP meeting because it highlights a potential flaw in system. The PRODUCT RELEASE procedure to be reviewed.
Hope it helps.