FDA visit to NJ HQ

Heard FDA is visiting. What's up with that??

 

Why else would they be raiding the headquarters?

 

They are shutting you down cause your CEO is a douche bag!

 

Off label selling??

 

Possibly a routine audit because the Bridgewater facility is a newly registered establishment? I wouldn't read too much into this one...yet.

 

Quantified rumour has it that this FDA audit is not routine...
It's the beginning of a much more expansive audit and it will impact ALL of Valeant.
So you better all cover your rear ends, because the finger pointing will be aimed at the lot of you, the lower on the corporate ladder you are, the more blame you will get.
Heads are gonna roll on this one...

 

So Valeant lays off your other five colleagues that help you to assure a safe and efficacious product. You are left to hold the fort and can not maintain the paperwork or do appropriate monitoring to assure that everything is OK.

You are then held accountable for bad paperwork, poor monitoring, lack of compliance etc.

Bottom line. If you find you are in this position you are better off getting a new job than to be legally liable with the recall or lack of compliance notes happen.

 

Tage and Peter should be very worried.

 

Pearson you can't buy the FDA off with donuts.

 

Nothing compared to the investigation pending on accounting irregularities.

 

The big boy can't run too far. There are two legal precedents which hold the CEO directly accountable for violations of the FD&C Act (see US v. Park and Dotterwich).

 

Did this ever happen?

 

Is this the queens of spades being pulled out from the house of cards? Here's hoping so

 

.... Not going well. Really need experienced people running the show. Oops, I forgot, none exist at Valeant.

 

Seems they are going fine. And got two drug approved. Not bad with no budget and few propel. That's pretty productive in my book

 

Do you mean Ann R?

 

What is the outcome of the FDA Inspection?

 

Mike Pearson here no worries I will paying them off.

 

They took a large quantity of documents but I have not heard anything else.

 

It was for manufacturing