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Letter of Compliance with Bioterrorism Act of 2001


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#1 lindsaysheppard91

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Posted 11 January 2019 - 02:36 PM

Good morning,

 

A prospective customer asked me to send them a "Letter of Compliance with the Bioterrorism Act of 2001", can anyone give me any insight of how I get this letter? We are registered with the FDA, but when I go on the FDA website and log in, I don't see anything regarding Bioterrorism. Any help would be greatly appreciated. Thank you :)

 

Lindsay



#2 FSQA

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Posted 11 January 2019 - 03:15 PM

Good morning,

 

A prospective customer asked me to send them a "Letter of Compliance with the Bioterrorism Act of 2001", can anyone give me any insight of how I get this letter? We are registered with the FDA, but when I go on the FDA website and log in, I don't see anything regarding Bioterrorism. Any help would be greatly appreciated. Thank you :)

 

Lindsay

Lindsay,

 

It is a letter that you/your company need to create on your letter head to show your customer that you are registered with FDA. The registration is a part of of the Bioterrorism Act.

 

I cannot share a letter here, however, a simple web search for some "bioterrorism act of 2001 food facility registration letter sample" will generate few letters for you to assist you preparing a letter.

 

Following is the link from FDA on this topic:

https://www.fda.gov/...ion/default.htm

 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

  • Food facilities register with FDA, and
  • FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.



#3 RickyFerrante

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Posted 11 January 2019 - 03:17 PM

Good morning, Lindsay.

 

This is something that your company needs to write up in house and send to the customer, signed by the QA Manager (or the appropriate personnel). It isn't something that is provided by the FDA.

 

I would read the Bioterrorism Act and, as long as your company is in compliance, write a letter saying you guarantee to be in compliance. It doesn't have to be long, just a few sentences will work.

 

I hope this helps you!

 

Have a great weekend!

 

Ricky



#4 lindsaysheppard91

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Posted 11 January 2019 - 07:53 PM

BIOTERRORISM ACT/FOOD DEFENSE STATEMENT

(OUR COMPANY) appreciate the opportunity to provide you with information relevant to our food security programs. Our manufacturing facility is regulated by the Food and Drug Administration (FDA) and subject to registration with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and the FDA Food Safety Modernization Act of 2001 (FSMA). As of January 11, 2019, our facilities are current with registration requirements for both the Bioterrorism Act and FSMA.(OUR COMPANY) has also confirmed that all our suppliers have complied with the above registration requirements, where applicable.

 

Because the disclosure of our specific food defense and security procedures would jeopardize our ability to sufficiently secure our process, our company keeps the details of our program, and the FDA registration number strictly confidential. Our manufactures abide by our strict supplier approval process and requirements to have tamper evident packaging. (OUR COMPANY) seek to continually improve our operations in order to maintain safe and secure products.



#5 lindsaysheppard91

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Posted 11 January 2019 - 07:54 PM

This is what I wrote :

 

 

BIOTERRORISM ACT/FOOD DEFENSE STATEMENT

(OUR COMPANY) appreciate the opportunity to provide you with information relevant to our food security programs. Our manufacturing facility is regulated by the Food and Drug Administration (FDA) and subject to registration with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and the FDA Food Safety Modernization Act of 2001 (FSMA). As of January 11, 2019, our facilities are current with registration requirements for both the Bioterrorism Act and FSMA.(OUR COMPANY) has also confirmed that all our suppliers have complied with the above registration requirements, where applicable.

 

Because the disclosure of our specific food defense and security procedures would jeopardize our ability to sufficiently secure our process, our company keeps the details of our program, and the FDA registration number strictly confidential. Our manufactures abide by our strict supplier approval process and requirements to have tamper evident packaging. (OUR COMPANY) seek to continually improve our operations in order to maintain safe and secure products.

 



#6 FSQA

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Posted 11 January 2019 - 08:06 PM

This is what I wrote :

 

 

BIOTERRORISM ACT/FOOD DEFENSE STATEMENT

(OUR COMPANY) appreciate the opportunity to provide you with information relevant to our food security programs. Our manufacturing facility is regulated by the Food and Drug Administration (FDA) and subject to registration with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and the FDA Food Safety Modernization Act of 2001 (FSMA). As of January 11, 2019, our facilities are current with registration requirements for both the Bioterrorism Act and FSMA.(OUR COMPANY) has also confirmed that all our suppliers have complied with the above registration requirements, where applicable.

 

Because the disclosure of our specific food defense and security procedures would jeopardize our ability to sufficiently secure our process, our company keeps the details of our program, and the FDA registration number strictly confidential. Our manufactures abide by our strict supplier approval process and requirements to have tamper evident packaging. (OUR COMPANY) seek to continually improve our operations in order to maintain safe and secure products.

Looks fine and probably will suffice your customer's request.



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