FDA Registration Number
Hello Everyone -
I was wondering if anyone could set the record straight on the topic of a facilities FDA Registration Number. In approving a supplier, can we ask for them to supplier their FDA registration number? Or does it suffice to just ask if they are in fact registered?
The reason for the question is I had heard that a facility should not give out their registration number and to treat it like a social security number as anyone could use it to import products under.
Anyone have any sound advice on which way to go on this subject matter?
Thanks so much!
I ask for the supplier's FDA registration. Most give it to me but some will not. For me, a letter stating they are registered will suffice. I will not give our registration number out to my customers either.
I agree not to share the number. I have a copy of the FDA registration page where I have blacked out our registration number if they absolutely need 'evidence' that we are registered. From our suppliers a signed statement that they comply with this regulation is enough for me!
I ask for the supplier's FDA registration. Most give it to me but some will not. For me, a letter stating they are registered will suffice. I will not give our registration number out to my customers either.
Hi RMAV -
Is there a reason that you do not give out your registration number? Still trying to understand if there is something wrong with sharing it even if we are asked for ours?
I'm alos interested in knowing why you wouldn't share your FDA registration number. Most of our vendors and customers are willing to share it, but I do have one that is very adamant about not sharing their FDA registration number.
I agree the registration number is not to be given out. We get asked for it a lot and I refuse to divulge it. The FDA states you are not supposed to give it out. If they need actual proof, I print out the registration page and black out the number.
Is there a written clause somewhere that registration number is not to be given out? I'm just curious everyone is saying no, but where is it coming from?
Think of the number like your pin number on your ATM card. While the number itself may seem harmless someone can call up the FDA with your number, give your facility name and address and create identity theft in a way with your company. Theoretically, they could cause havoc with the bioterrorism registration.
Is that a real risk? Who knows, but I wouldn't take the chance. Everyone accepts a statement in place of providing the registration number.
Think of the number like your pin number on your ATM card. While the number itself may seem harmless someone can call up the FDA with your number, give your facility name and address and create identity theft in a way with your company. Theoretically, they could cause havoc with the bioterrorism registration.
Is that a real risk? Who knows, but I wouldn't take the chance. Everyone accepts a statement in place of providing the registration number.
Ditto Ryan.
In addition, if a supplier refuses to pass it on to you, keep in mind that the number is useless to anyone but FDA. FDA does not share any registration information or status, so you couldn't use the number yourself in any way to confirm identity, registration, etc. And it is not illegal to purchase food from an unregistered facility, but it is illegal to sell food from an unregistered facility. In that way FDA protects you when purchasing products and places the compliance burden on the vendor.
If they will not give you the full FFR #, ask for the last 4 digits. Also, ask for the registration date. They should have registered 4th QTR 2016 and will need to re-register every 2 years.
Is there a written clause somewhere that registration number is not to be given out? I'm just curious everyone is saying no, but where is it coming from?
I remember reading that somewhere on an FDA website. Maybe it was when I was going through the registration process - of course I can't find the citation...
I remember reading that somewhere on an FDA website. Maybe it was when I was going through the registration process - of course I can't find the citation...
This bothers me - I can't find it so I'm thinking I read it somewhere else. I'm joining majoy in asking, where is this written?
I agree that it was in one of the FDA Q&A's. Likely one of the broken/circular link ones they have all over their FSMA pages.
They're in edition 7 of this guidance which no longer has the specific language, just the below guidance:
https://www.fda.gov/...n/UCM332460.pdf
M.2 Is a registered facility responsible for ensuring that the companies with which they deal are registered?
There are no direct penalties for doing business with a company that is not registered. However, if a company offers food for import into the United States and the food is from a foreign manufacturing facility that is not registered, the company may be unable to complete the prior notice for the shipment (21 CFR 1.281(a)(6)), which is required to import the shipment.
M.3 Is a facility required to provide its food facility registration number, assigned by FDA when the registration is submitted, to customers or other businesses who request the number?
Is a facility prohibited from revealing its registration number? Section 415(a)(5) of the FD&C Act provides that certain registration-related information, including the registration number, is not subject to disclosure under FOIA. However, this does not prevent a facility itself from disclosing such information. In fact, for imports, a facility will Contains Nonbinding Recommendations Draft– Not for Implementation 59 likely need to provide its registration number to any downstream commercial entity who will be submitting prior notice for a food manufactured by the facility (see 21 CFR part 1, subpart I). The FD&C Act does not prevent a foreign facility from entering into an agreement with its customers to limit the circumstances in which the facility’s registration number may be disclosed to third parties.
M.4 FDA’s list of facilities and registration documents are not subject to public disclosure. How do we know that a supplier, for instance, is registered?
Section 415(a)(5) of the FD&C Act provides that certain food facility registration information is not subject to disclosure under FOIA. However, disclosure of such information by the facility itself is not prohibited. FDA expects that generally, foreign suppliers and their customers will resolve this question as part of their agreement to buy and sell food for consumption in the United States.
I remember reading that somewhere on an FDA website. Maybe it was when I was going through the registration process - of course I can't find the citation...
I was told by auditors that would come into our facility. Auditors that were third-party and also customer auditors. It made sense so I discontinued any communication of the specific registration number even when requested.
I've never had a customer or other entity try and force my hand in obtaining our registration number so it obviously isn't a huge deal to have the specific number. The entity likely just wants to ensure you are registered.
Ditto Ryan.
In addition, if a supplier refuses to pass it on to you, keep in mind that the number is useless to anyone but FDA. FDA does not share any registration information or status, so you couldn't use the number yourself in any way to confirm identity, registration, etc. And it is not illegal to purchase food from an unregistered facility, but it is illegal to sell food from an unregistered facility. In that way FDA protects you when purchasing products and places the compliance burden on the vendor.
Hi 3F,
Thks for pdf Post 13.
A few observations from an "uninvolved" regarding this complicated thread.
(1) I noted this "caveat" paragraph in pdf of post 13 -
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
(The reality/interpretation on the ground may of course be sometimes "rather" different)
(2) I have not yet seen any specific validation of yr "red" comment in 1st quote above ? Is it supposed to be self-evident ? "M2" (see below) appears to simply warn of potential (unspecified) import difficulties. (i searched the pdf for "illegal"/"not legal" without success)(Perhaps it's validated somewhere else).
(3) Since the guidance specifically disclaims any requirement for FDA number disclosure + it's apparently zero verifiable, I'm surprised a simple statement has not become routine. On the other hand if resale from unregistered suppliers is truly illegal, I can understand a buyer's pursuance of more than "just a letter". The EC operates an aanalogous scheme for approved "3rd world" seafood suppliers but their list of approved facilities/ numbers is afaik accessible.
M.2 Is a registered facility responsible for ensuring that the companies with which they deal are registered?
There are no direct penalties for doing business with a company that is not registered. However, if a company offers food for import into the United States and the food is from a foreign manufacturing facility that is not registered, the company may be unable to complete the prior notice for the shipment (21 CFR 1.281(a)(6)), which is required to import the shipment.
I always take the view that guidance=enforceable, but not defensible. :)
Reference of legality for you:
https://www.fda.gov/...l/ucm122876.htm
The Bioterrorism Act makes failure to register a prohibited act under § 301 of the FD&C Act.
Addendum: there's also a bunch of warning letters, and FDA can "revoke registration" if they deem necessary as an action to "prevent" you from selling food since you would be in violation.
https://www.fda.gov/...m/UCM521045.pdf
Of course, again, revocation is a meaningless enforcement tactic since suppliers have no way of knowing whether a facility was registered in the first place since FDA does not share that information..
Can you hear my frustration with this requirement?