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Welcome my name is Mark Sanchez senior counsel of founder of contract in House Counsel of consultants FDA ADI Andre're here today to talk about a very important issue form 43 the observations that occur within a facility that can lead to a warning letter in particular#39’re going to look back at 2013 for the top 10 observations in 3 FDA regulated categories to find out what that list of common observations are in order to better prepare for that inspection whether it be in surveillance or for cause and determine how we can shapewhat'’s going on in a facility to better prepare for this most common enforcement mechanism we see from the Food and DrugAdministration so we#39’re going to begin by coming back to a question that#39’s very important we have some presentations that talk about to form 43 warning letters the relationship and in particular how to address and respond to form 43 but to make sure that we'real started on the same page today were going to look at the form 43 of this slide and then get into the most common observations so form 43 is an enforcement tool that follows an inspection it occurs for all FDA regulated products if you are regulated by the FDA then you will experience form 43 at some point and this is called an inspection operation, and it is juntas it describes it#39’s a list of observations a significant and minor typically the minor ones are talked Toby investigators to the facility owner or manager during that time so really the form 43 catches all of this significant violations or potential violations are included in that form this inspection can be routine so valence it can be a PRE inspection approval for devices it can be domestic and foreign, and it can also be for cause meaning that the FDA has a belief that either in this facility or a supplier or some components relate related to this facility is involved in a recall and adverse event or some other complaint that would require the FDA to come and investigate the observations are then reviewed they go from a field investigator to a district director or center director along with what's called an establishment inspection report andtogetherthis tells the FDA side of the story about how these are potential violations the significance of these violations and whether these violations warrant warning letter but again there are only one halves of the story, and it's very vital to respond and to provide the facility side of the story as well and that response only has 10 days to redrafted and that#39’s a very critical and short time frame to provide a response but that's the time that the FDA gives you is 10 days to develop a response significant violations will lead to warning letter so does a poor response if a response is fired off as soon as you get the form 43 then the FDA is left with the impression and this is the conversations that we#39’ve had with many compliance directors in the district offices is the FDA gets the impression that the facility doesn't#39’t...
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