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Bioterrorism Statement and FDA FSMA Statement

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#1 stevenson111

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Posted 06 September 2019 - 04:29 AM

Hello,

I have written an FDA Facility Registration Statement for a customer.  I have received other requests for a Bioterrorism Statement and an FDA FSMA Statement.  What is the difference in these last two statements and my facility registration statement?  Can someone give me an example of the Bioterrorism Statement and FDA FSMA Statement?  I am having a hard time understanding what they want differently and how to word it.

Thanks in advance for any help.

 

 

Val



#2 kfromNE

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Posted 06 September 2019 - 12:16 PM

My belief is that a bioterroism statement refers to your intentional adulteration program. So something along the lines of we have a food defense program in place including protecting from intentional adulteration. We test it annually....



#3 stevenson111

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Posted 06 September 2019 - 01:56 PM

What about the FSMA letter?  How is that different? 



#4 MsMars

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Posted 06 September 2019 - 02:28 PM

What about the FSMA letter?  How is that different? 

 

FSMA statements generally refer to the site's compliance with FSMA regulations, it doesn't have to be too complicated.  I think in the past I've just created a general letter that stated along the lines of "Company A is in compliance with FDA Food Safety Modernization Act of 2011 and actively employs a food safety program that includes (hazard analysis, preventive controls, allergen controls, sanitation program, etc., whatever your program includes).  Details of this program are available for review at our facility upon request..."


Edited by MsMars, 06 September 2019 - 02:28 PM.


#5 kfromNE

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Posted 06 September 2019 - 03:07 PM

What about the FSMA letter?  How is that different? 

 

They don't have to be different if you specifically mention Food Defense including intentional adulteration in your FSMA letter.

 

https://www.ifsqn.co...sm-act-of-2001/ - for examples of how to write it and combine with your FSMA letter.






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