Friday, February 10, 2012

FDA Inspectors Crave a Good Hot Cup of CAPA

Looks like companies are still having the same problems.

FDA Inspectors Crave a Good Hot Cup of CAPA:
"An analysis of 2011 and 2010 FDA inspection observations in 483s shows clearly that CAPA remains at the top of the charts for the FDA (see charts below). FDA’s own analysis of its 3,434 483 observations in 2010 found that CAPA was the number one, with a total of 1058 citations. Number for 2011 aren’t yet available, but there’s no indication they are going anywhere but up.
And that’s probably not going to change in 2012, either."
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