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Formulario 483 2

Formulario 483 2

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I want to thank everybody for attending this presentation on FDA 43s in the laboratory where we're going to be talking about some reviews of current issues as seen by the FDA uh when they do their audits or inspections and we broke down the data here is a breakdown of the data FDA 483s and we looked at roughly 216 inspections a little over 2200 observations in total and broke them down into the areas the pieces of the pie in which the observations were made roughly 20% fell in quality 21% in facilities and equipment and 21% in the laboratory 18% roughly in production materials at 12 and then you've got a few little things packaging labeling at five then a mish mash of other things just came up to about 3% of the total of the entire Pi breaking down this further we'll go to the next slide and this broke down the laboratory system 216 inspections performed uh just under 500 observations in total 477 broke it down into where are the major areas of flaw where people

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