8 replies to this topic

[SHQuality]

I've run into another FDA registration issue that is causing me problems.

I hope someone on the forum will be able to provide helpful advise.

 

One of my customers is claiming that they've got an FDA registration certificate, but that they're only allowed to share the registration number. I've asked one registrar if they have those numbers on file. No dice, they were not the registrar that registered those numbers.

 

There is no public database to check.

 

How can I figure out if the number provided belongs to the company in question and how long the registration is valid for if they refuse to provide the document? Am I supposed to just drop their approval for American customers or is there an alternative I'm not seeing?

[kfromNE]

https://datadashboar...v/ora/index.htm - This FDA website may have the info you are looking for.

[SHQuality]

Unfortunately, that site doesn't list the company in question as far as I could tell.

Thanks anyway. It's a great resource.

Edited by SHQuality, 17 February 2023 - 12:48 PM.

[kfromNE]

Show them the regulation and state this is what I need.You may have to leverage the fact that if you don't get the info - you'll have to drop them for American customers.

Funny/not funny enough - getting USA companies to comply with US rules and give you documentation you need - can be very difficult too.

[PieGuy191]

If they have a registration certificate from FDA, have them make a copy and blot any proprietary info and send a copy to you.  We provide our customers upon request, a copy of the FDA certificate (it has the FDA letterhead on it) with all but the last 4 digits of the registration number and the Pin# redacted.  It shows the company name, address, and dates of registration and expiration.

 

No one has ever had a problem with that.  The FDA does not require you to give out the registration number and since they do not maintain a searchable database it is a moot point.

[mgourley]

Agree with PieGuy.

 

When you register/re-register on the FDA site, you can simply print/PDF the registration information.

You redact all but the last four numbers of your facility registration number and your PIN and then share that with those that ask for it.

 

This is not a huge ask from your suppliers.

 

Marshall

[SHQuality]

If they have a registration certificate from FDA, have them make a copy and blot any proprietary info and send a copy to you.  We provide our customers upon request, a copy of the FDA certificate (it has the FDA letterhead on it) with all but the last 4 digits of the registration number and the Pin# redacted.  It shows the company name, address, and dates of registration and expiration.

Funnily enough, my suppliers don't have a problem with sharing their registration number.

Still, what is the point of registering if that registration can not be searched or otherwise verified?

 

I have finally managed to get the supplier to send a redacted version of the document, but I'm still interested in what the added value is of this particular registration when there is no way to check if the supplier is making up a fraudulent fake number.

[Bo16]

Maybe they will provide the DUNS number so you can check them out as well?

[G M]

... I'm still interested in what the added value is of this particular registration when there is no way to check if the supplier is making up a fraudulent fake number.

 

It is useful to the FDA, not to anyone else.

 

I agree with you though, it would have made far more sense to have a publicly searchable system and a requirement to have that number on finished goods.  Maybe in a few decades the FDA will come to the same conclusion everyone else has.