Saturday, February 18, 2017 1:10:32 PM
Dew,
We're only guessing at this point of what the problem is because we lack any of the real statements from the FDA.
If this is a Hospira facility, the odds that the problem could be major (system wide) would be much higher than if it were in an Pfizer (stateside) facility.
Hospira has always operated on a shoestring budget compared to the likes of Pfizer. Many years ago they settled many problems with the FDA, yet a year later the FDA inspected them and found none of the solutions or promises were instituted. They've had a target on their back since. Last year, a week after announcing a $200 mil fix up for a Hospira plant in Colorado Pfizer decided to close it instead.
Let's remember, that if Momenta truely stated that PFE received a FDA Letter, the Letter (deficiency notice) is normally the 3rd piece of contact that something has not been resolved. So this is nothing new, just that it's escalating.
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