Facts - while the G guys were telling you how bad you were at compliance they received a total of 3 separate 483s in SSF from September 2011 to October 2012 - plus a fourth in early 2014. Likewise the Vacaville site received 2 FDA 483s from March 2012 & September 2013. Additionally, the crown jewel fill and packaging site in Hillsboro Oregon took 483 in June 2012.
The SSF site got more 483 items in 13 months than you got in 13 years.
All this while the G QA team was telling Roche how good G was and how bad R was. R HQ was in love with G.
But some consultants got rich off of you.
G is great at Research and Discovery - weak everywhere else.
And that is why you will always get 483s... you don't realize that it IS important. And that's why the EMEA is always down't GNE's throat. GNE doesn't care... I think that's good for customers to know.Getting a 483 is no big deal. Everyone gets them . So what. Carolina sucks.
Getting a 483 is no big deal. Everyone gets them . So what. Carolina sucks.
FDA met with GNE QA buffoons (Pinion's minions - soon to be cleared out for good) and told them FDA is sick and tired of GNE pushing them around with much needed brake thru thrapies, and honeymoon is over. No wonder so many of the Pinion's rats are jumping boat including LV and even air head ex-head of audit EE.
Even the head honcho of biologics TM was forced out and before he got booted he was forced to fire the head of DS and DP in SSF lah-lah land and even his protege TH left. And JM got pushed out even with Samsung TT hoopla.
Yep rats fleeting sinking ship and beyond stacking chairs as FDA is playing the last tune.
LOL - you derseve the FDA wrath you bunch of SSF assholes who made us look like complete hicks.
OMG the last sentence above made me roll on the floor laughing. How true! They are not Class A but propagandize that they are and believe their own bullshit. Most definitely believe their own shit doesn't stink. What a joke. And to top it off, look at what the biggest Class A ass Jami did... surrounded herself with losers like Mazz and Muir and Hinson and Space. There is talent judgment for you along with her other poor judgments.
FDA met with GNE QA buffoons (Pinion's minions - soon to be cleared out for good) and told them FDA is sick and tired of GNE pushing them around with much needed brake thru thrapies, and honeymoon is over. No wonder so many of the Pinion's rats are jumping boat including LV and even air head ex-head of audit EE.
Even the head honcho of biologics TM was forced out and before he got booted he was forced to fire the head of DS and DP in SSF lah-lah land and even his protege TH left. And JM got pushed out even with Samsung TT hoopla.
Yep rats fleeting sinking ship and beyond stacking chairs as FDA is playing the last tune.
LOL - you derseve the FDA wrath you bunch of SSF assholes who made us look like complete hicks.
FDA met with GNE QA buffoons (Pinion's minions - soon to be cleared out for good) and told them FDA is sick and tired of GNE pushing them around with much needed brake thru thrapies, and honeymoon is over. No wonder so many of the Pinion's rats are jumping boat including LV and even air head ex-head of audit EE.
Even the head honcho of biologics TM was forced out and before he got booted he was forced to fire the head of DS and DP in SSF lah-lah land and even his protege TH left. And JM got pushed out even with Samsung TT hoopla.
Yep rats fleeting sinking ship and beyond stacking chairs as FDA is playing the last tune.
LOL - you derseve the FDA wrath you bunch of SSF assholes who made us look like complete hicks.
LMAO! Ain't that the truth! Those four clowns and our current site head are like the smell of skunk...you have a hard time washing off their shit ass odor from your body whenever you encounter them!
And that is why you will always get 483s... you don't realize that it IS important. And that's why the EMEA is always down't GNE's throat. GNE doesn't care... I think that's good for customers to know.
No buy out, Roche gave Patheon the plant. Nice to know that the site will get back into the business of manufacturing and releasing product without the Police State Quality system Genentech forced down our throats.
