Relabeling due to FDA Detention Notice

[dnormand]

I am a foreign manufacturer that has shipped Class II medical devices to our distributor the US. Upon Inspection FDA noticed some labeling issues which require our attention. Can I use our US Distributor facilities to re label the devices? Re lebeling will require a over sticker addition "Rx Only".

 

[MIREGMGR]

Re: Relabeling due to FDA Customs Detention Notice

Your post suggests that the devices reached your distributor, but the thread title says they're detained.

If your distributor has them, I'd think you could re-label them there. If they're in a Customs warehouse, you'll have to ask Customs if the goods can be moved to another secured facility where they can be modified by your distributor or another party for re-inspection.

Note that "FDA" and "Customs" are two distinct agencies with separate requirements. It's a good idea to be clear on which you're referencing at a given time.

 

[dnormand]

Re: Relabeling due to FDA Customs Detention Notice

Thanks for your reply. You are correct that the shipment was released
by customs then detained by FDA then ultimately released for shipment
to be held "intact" by our distributor. That is where we are at. I
guess the real question is are there any special requirements that
would prohibit us from relabeling at the distributor for FDA inspection?

 

[MIREGMGR]

I don't have any experience with your situation ("...released for shipment to be held "intact" by our distributor..."), and I don't have a copy of PREDICT rules that would define that direction or restriction. Do I correctly understand that you may not distribute until a further FDA release?

If so, then I'd think you'll need an OK from FDA in writing before making any changes to the products.

 

[Ajit Basrur]

Re: Relabeling due to FDA Customs Detention Notice

Thanks for your reply. You are correct that the shipment was released
by customs then detained by FDA then ultimately released for shipment
to be held "intact" by our distributor. That is where we are at. I
guess the real question is are there any special requirements that
would prohibit us from relabeling at the distributor for FDA inspection?

Could you specify the reason for FDA detention ?

 

[MIREGMGR]

Detention is discussed in several guidances. One says:

Detention is the action that FDA takes against imported medical devices that do not comply with the laws that FDA administers (21 CFR 800.55)). FDA may detain imported medical devices whenever physical examination or testing of a medical device, or examination of medical device labeling and labeling claims by FDA show that the medical device violates FDA laws. The importer of record may file an appeal requesting an informal hearing. A presiding FDA officer will affirm or revoke the detention. Detained devices are either released if brought into compliance or refused entry if not brought into compliance.

This unfortunately doesn't address the specific issue, i.e. whether you can proceed on your own with the "bringing into compliance" labeling change, or instead must have permission from FDA before changing the detained product.

You might want to call DSMICA and ask. If they don't know either, they'll probably point you to someone within FDA who can answer definitively.

 

[dnormand]

The product was detained due to "Rx Only" labeling. It is a clear violation and was a mistake not picked up from our Quality Systems. We choose to remove the "..for use only under the supervision of.." and put the Rx Only but did the former and not the later.

We now have to relabel tens of thousands of pieces

thanks for the comments and help