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2020 FDA Top Ten Observations

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Tidge

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#4
I see no real surprises, except for the net 2020 count against all Design Controls areas (820.30 ff) being (only?) on the order of 150. The net total is certainly lower than in past years (compare 2012 for example).

I'm not surprised about CAPA being so high (see past years) on the list considering that it will be examined as part of the QSIT approach, and flubbing "appropriate data sources" for the CAPA system is an easy finding if there is daylight between the QSR and what is happening at the manufacturer (e.g. NCRs, Complaints). For example: MDR gets some attention in the QSIT guide as well, but IMO it ought to be much easier to satisfy the MDR parts of QSIT; I wouldn't be surprised if almost every observation in the MDR space didn't also have an observation in the (focused) CAPA space.
 
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