Merck Boulder

How did management react?

 

Management was not happy obviously, but recognize there is only so much they can do with an inept workforce...they need better support from those on the floor

 

I would think management would be at fault. They should enforce GMP. Has Coherus replied to the problem?

 

When did this happen?

 

Pretty bad! Never heard of the FDA doing so before.

 

I have not heard any announcement about this.

 

If this is true, which I don't know, when will it be made public?

 

The poster may have been lying since they have not answered a single question.

 

It would be nice to know some of the facts about this.

 

you all are bunch of idiots, the CRL was due to issues with the submission and had nothing to do with the FDA inspection. KBI got the pre-approval even with a list of 483s. Coherus is refiling and their competitor is behind them now too because they also got a CRL from the FDA. Talk about fake news, this is ridiculous.

 

I head from a KBI employee that KBI had dozens of 483s! How do they stay in business? Coherus is almost a dead company....look at their low stock price and the denial of nearly all their court actions. I believe there is great truth in the denial due to KBI's lack of GMP and ethics.

 

Any pharma company with an inspection with more than 1 or 2 483s should be ashamed of itself! There are federal regulations designed to protect consumers and if you have many 483s you are a danger to consumers and should be shut down! There can be no argument!

 

You are a complete idiot! No on knows what the CRL says because Coherus has NEVER made the CRL public. We only know what Coherus says and they are losing millions everyday and will be gone in a year. Coherus' competitors are way ahead in the game. You must be an Associate at KBI because you know nothing!

 

Hilarious how a few people try to defend KBI. You cannot defend them because they are irresponsible.

 

obviously some one uneducated in regulatory inspections trying to stir the pot, 483's with multiple findings are common across the industry...the number of findings is not the concern, but rather the severity of the findings...go back to cleaning the toilets and stop trying to cause problems...

 

Obviously, you should be a janitor. Anything above 1 or 2 483s is way beyond the normal and accepted. KBI had 9 483s!!!!! The FDA returned and gave KBI at least a dozen more 483s!!! Many of these were severe 483s! The poster must be a compliance member at KBI or one of their ignorant managers.

 

Was it like that in Rocky Mt NC and Austin TX ?

 

The Texas site is new and I do not know about NC. Boulder is a disaster. They push to get too much accomplished in not enough time. The turnover rate is 95%+. All the good experienced workers left for other pharmas. You just cannot cut corners with biologics.

 

Check out the KBI reviews on Glass door.com.

 

KBI is a poor company. They don't follow any regulations and their management is a bunch of simpletons.