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Generic Inspection Form

Generic Inspection Form

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thank you good afternoon uh i'm going to jump right into it i have a lot of material to cover i know this is one of the hot topics facilities and inspection everybody loves this so for the next 20 minutes we're going to talk about the goals of the facility assessment within your applications what's the difference between a facility and a process that chad just talked about subtle differences what goes into our risk-based decisions in our facility assessments how we come about our pai decisions and our outcomes i'm going to talk a little bit more about the back end of the pii as opposed to the pi itself different types of information requests our office has one additional information request that we can send out outside of the ir and then we're going to wrap it up with some examples of the facility recommendations so you might ask yourself why this facility requirement why do we pay attention to facilities well it's in the food drug and cosmetic act that we cannot approve a application

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