Ooops, we did it again

Anonymous

Guest
How come we systematically ignore the basics of drug makers? Did anyone in charge (incl Corporate Management) ever took classes like "CGMP 101"? Do they understand what manufacturing and drug development is about? Or at least have they 'read and understood' NVS SOPs?

Reading the inspection report and knowing it is a NVS site is embarrassing. http://www.fda.gov/downloads/AboutF...cy/ORA/ORAElectronicReadingRoom/UCM285976.pdf

First 3 Sandoz plants, now NVS in Lincoln, what's next if this may be just the tip of the ice berg?

Aside from the reputation, the financial damage will be noticeable but for sure the bonus for Dan, Joe and David will not be affected ...
http://www.pharmalot.com/2012/01/the-novartis-recall-and-560m-in-lost-sales/
 






FDA is really pissed off:

THIS IS A REPEAT DEFICIENCY FROM THE PREVIOUS INSPECTION AT YOUR SITE, DATED 4/5-16/10.

THE ABOVE EXAMPLES REPRESENT A PATTERN OF PROBLEM AT YOUR FIRM WHERE INVESTIGATION CONCLUSIONS ARE MADE WITHOUT JUSTIFICATION.