Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

most of the commitment made to the FDA following that inspection

There are problems that will take a a lot of time to resolve.

I'm not sure but my best guess is that Pfizer had a CGMP section Titled : Don't Put Cardboard in a Vial in their Guidelines, yet for some reason cardboard got into a vial.

That's not a problem (sheet happens) but the real problem was that Pfizer not only didn't catch it but it also didn't deal with the situation on many fronts when it realized the problem such as recalls, notifications, product quarantine etc.

This is not a problem of writing another CGMP policy, it is a problem of implementing your current guidelines and there's no solution to that problem except execution over a given timeperiod. Pfizer lost the faith of the FDA and it will take many repeat visits to gain the trust back.