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Proof of Bio Terrorism Registration


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#1 fgjuadi

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Posted 22 September 2014 - 07:38 PM

Hi

 

We do not give out our bioterrorisim registration number (as this can be used to illegally ship items in our name).

 

What kind of proof do you look for when a customer or auditor asks to see bioterrorisim registration? 

 

I don't have anything from the FDA that says I am registered but does not have the number (and PIN) written on it, and I'm not sure what to provide when asked for proof of registration.


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#2 Slab

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Posted 22 September 2014 - 08:27 PM

Hi, Magenta;

 

That is an odd request, and honestly I was not aware there was a separate number for FDA registered facilities.  Normally questionnaires ask if you are registered which is pretty much a "'duh' circle YES". You are not (or should never be) contractually obligated to provide such information to 3rd parties without signed non-disclosure.

 

If you are regulated by FDA then simply provide them either your CFN or FEI number (IIRC on FDA From 3514).  You can no longer produce for commerce without Bioterrorism legislation, so the two go hand-in-hand.


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#3 Snookie

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Posted 22 September 2014 - 11:57 PM

I have had auditor's verify our number but not customers.  I believe there is (or there used to be) a certificate you could print out.  Packaging is exempt so I don't worry about it now. 


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#4 jenky

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Posted 23 September 2014 - 12:16 PM

I have run into this issue many times - several customers have requested our facility registration number to "verify" we are in compliance.  In response to these requests, we provide a simple written statement that says we are in compliance with the Bioterrorism Act and related FDA facility registration requirements.  The statement also makes mention that the FDA rule provides that facility registration documents are confidential and not subject to disclosure under FOIA.  Not a single customer has objected. 

 

During an audit, I have auditors verify registrations by looking at a printed copy of the registration but never copy the number down to include the audit report. 


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#5 Mr. Incognito

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Posted 23 September 2014 - 12:24 PM

At my previous position, where I handled all of the supplier documentation, our questionnaire asked if they were registered and what their number was.  Some people provided the number where other people would check that they were registered but that they weren't able to disclose the number... at some point you have to take people at their word I guess.


Edited by Mr. Incognito, 23 September 2014 - 12:24 PM.

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#6 fgjuadi

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Posted 23 September 2014 - 01:20 PM

Yes, mostly it is requesting for info along the lines of " We need your annual Product specification, HACCP plan, LOCG, Proof of Insurance, Bio Terrorism Registration, 3rd party audit, ...etc"

 

I'm currently using a form letter like the ones I make for GMO statements or HACCP plan "We do not give out detail of our HACCP blah blah, we do not have a current non-GMO certification blah blah, we do not give out our bio terrorism registration number, blah blah".  I guess more people are asking because FSMA is focusing on food defense and it's an easy audit check for the purchaser.  I can't find a certificate or anything.  Seems like "We don't disclose" is a pretty common answer


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#7 PetBone

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Posted 23 September 2014 - 01:39 PM

I have had several customers ask for this to insure compliance on our behalf. We have always provided it without any questions.


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#8 ShannonH

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Posted 24 September 2014 - 07:08 PM

We ask for this from our vendors.  All I am asking for is something on letterhead that states that you are registered.  Some even provide the last four digits or a partial identifier.  You would be surprised how many people do not realize that they are not supposed to give out their numbers, I have several!


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#9 jamesdlm

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Posted 24 September 2014 - 07:37 PM

We provide a copy of the confirmation letter with the actual number blacked out. One auditor asked if we had an 11 digit registration number, and asked that I go and verify that it was in fact 11 digits from a non-blacked out copy, and then took my word, the other audits have not asked for any evidence or a digit count, they have simply asked if we are registered and the yes has been sufficient.


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#10 CaliforniaFS

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Posted 24 September 2014 - 07:56 PM

I provide the registration number from the FDA Facility Registration site.

 

If the auditor/customer accepts your word for it than I think that is sufficient.

 

If your customer or auditor was to call the FDA to verify you are registered, the FDA will not disclose any detail to them. 


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