I was reading this FiercePharmaManufacturing's Article on Novartis' CEO under a Regulatory Cloud.
So I got to thinking... how many FDA 483s are these guys getting?
It turns out, Novartis - across all their businesses has gotten at least nine 483s since 2009.
Fierce is doing a good job tracking Novartis' quality problems. I'm just letting you know how to get your hands on their 483s.
So I got to thinking... how many FDA 483s are these guys getting?
It turns out, Novartis - across all their businesses has gotten at least nine 483s since 2009.
- 17 observations made at the Liverpool UK site in 2011
- 14 observations at the Emeryville site in 2010
- 8 observations at the Vacaville site in 2011 after 5 observations from 2009
- 5 observations at Suffern NY in 2010 after 4 observations from 2009
- 1 observation at Brea in 2011
- 13 observations issued in 2011 after 2 observations at Lincoln, NE in 2010
As Eleanor Roosevelt once said, "Learn from the mistakes of others. You can't live long enough to make them all yourself."
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