Carver Shock Software removed from FDA website?
I was looking for CRAVER SHOCK software on FDA website but it is removed.
I want to know if somebody can help me and provide me a link to download or share with me the tool.
Many Thanks. :)
I´ve been following this issue and I asked to FDA, please find the answer:
¨FDA is currently developing extensive guidance documents to help industry comply with the IA rule.
In addition, FDA will be updating our food defense tools and resources, including the Food Defense Plan Builder. This user-friendly software program is designed to assist owners and operators of food facilities with developing personalized food defense plans for their facilities. However, the current version of the Food Defense Plan Builder on FDA’s website, as well as the CARVER+Shock vulnerability assessment software, would not produce a food defense plan that is compliant with the rule.
Please note, the IA rule does not apply to retail/foodservice establishments, nor does it apply to the holding of food, except the holding of food in liquid storage tanks. Therefore, facilities exempt from the IA rule can choose to use any food defense methodology they wish, however, we would recommend that they considering using FDA’s Food Defense Plan Builder software to develop their food defense plan¨.
Meanwhile I ¨mix¨ PAS-96 approach and the FDPB structure in order to fix as possible the latest IA guidelines.
Hello members,
I am also looking for CARVER+ Shock tool but the above-mentioned link is not working. kindly help me out.
Kind Regards,
I can not find the software either.
Does anyone know if the plan builder has been updated to comply with the rule?
Not sure but the FDA did just release in the beginning of March a second installment of the draft guidance about the Intentional Adulteration rule
https://www.fda.gov/...n/UCM611043.pdf
https://www.fda.gov/...n/ucm610946.htm
If you subscribe to https://www.ifsh.iit.edu/fspca - you will get updates on when new documents have been release - that's how I found out about it.
Not sure but the FDA did just release in the beginning of March a second installment of the draft guidance about the Intentional Adulteration rule
https://www.fda.gov/...n/UCM611043.pdf
https://www.fda.gov/...n/ucm610946.htm
If you subscribe to https://www.ifsh.iit.edu/fspca - you will get updates on when new documents have been release - that's how I found out about it.
Hi KfromlA,
Thanks for links.
"Adulteration" / "Vulnerability Assessment" = "Defense" ?
One wonders when the FDA will stop using GFSI fraud terminologies for the former's Food defense.
Then again, seems likely the FDA used them first. :unsure: