thromboembolic events, recalls and Noncompliance - oh my











































Does Judy know much about the plasma business? I don't think so. Judy never talks to our centers and is very condescending to the operations people. Plasma centers. "Ick"
 


















lol, just audit this POS - skip the warning letter and shut the bitch down.
Donor Safety issues - check
Product Quality issues - check
Unresolved trends - check
Ineffective CAPA - check
Product recall -check
Inconsistencies across centers -check
Failure to comply with CAPA for previous 483 items - ..you got it.
LMFAO
 












lol, just audit this POS - skip the warning letter and shut the bitch down.
Donor Safety issues - check
Product Quality issues - check
Unresolved trends - check
Ineffective CAPA - check
Product recall -check
Inconsistencies across centers -check
Failure to comply with CAPA for previous 483 items - ..you got it.
LMFAO

"Bring out the Gimp"
 


















Ship is truly going down, also major layoffs at the manufacturing plants..... plasma on stock beeing sold off to CSL and Bax....
FDA audited Vienna earlier this year, major non compliances were found, FDA also about to hit another plant early next year.....
Will be at least 6-9 months before FDA lets ANY Octagam back on the market, EU authorities still to come with their verdict but its not looking good.
 






All of this happened because they refused to join PPTA's voluntary QSEAL program. Now they are suffering the consequences of their arrogance and self-adulation! Mr. Magoo, you really messed this up big time. I'm surprised PPTA didn't vote you out of the association long before you decided to save face and leave under your terms. And the band played on!