Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

The 483 findings are disturbing and aren't going to be rectified overnight. Pfizer now has spent almost 10 months dealing with these problems and if they aren't at the goal line yet they won't be there soon. If this gets resolved in 2017 we'll be lucky.

I believe I saw 5 REPEAT violations which had 483's from 2012, 2013 and 2014. That means they need a babysitter because as an organization they are not living up to their previous corrective actions and are repeating previously noted violations. Sad.

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm546385.pdf