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Can Your Risk Assessment Stand Up Under Scrutiny?
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edbellis
edbellis,
User Rank: Apprentice
10/30/2017 | 1:12:15 PM
Well said
It's particularly important that organizations are acting on the results of these assessments and feedback loops get incorporated into the process. As Ray mentioned, if it just ends up as a report on a shelf not only is it a waste of time and resources, it can be deemed negligent.
FIGSYS017
FIGSYS017,
User Rank: Apprentice
7/27/2017 | 10:04:58 AM
FDA not FTC
The comments were made by the FDA, some part of the warning letter on April 12 2017 https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm552687.htm - not FTC. Different organizations.


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