Merck Boulder

[anonymous]

it will become more public in the coming weeks...

Might have to do with the R-Trypsin KBI was making. KBI took down their R-Trypsin sales site rather quickly this week. Maybe they were not authorized to make R-Trypsin or something was wrong with the product.

 

[anonymous]

What's going on there now?

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

 

[anonymous]

KBI site is running in complete compliance. You fired non skilled plant workers can eat crap.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

So why are all of the "Senior Directors" and "Vice Presidents" driving expensive company-paid vehicles?

 

[anonymous]

So why are all of the "Senior Directors" and "Vice Presidents" driving expensive company-paid vehicles?

Getting what they can before the Boulder site is closed.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

What Coherus Drug? I know Coherus 1701 was rejected months ago.

 

[anonymous]

KBI site is running in complete compliance. You fired non skilled plant workers can eat crap.

HAHAHAHAHA!!!! KBI was turned in by a KBI employee from what I heard at KBI!!!

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

KBI had 9 483 observations in their only FDA inspection. 9!!!!! That is unheard of for a pharma company making biologics! KBI should, and maybe they will, receive an FDA warning letter. All KBI workers in Boulder should be ashamed!

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

Which Coherus drug was it? What GMP Violations?

 

[anonymous]

KBI had 9 483 observations in their only FDA inspection. 9!!!!! That is unheard of for a pharma company making biologics! KBI should, and maybe they will, receive an FDA warning letter. All KBI workers in Boulder should be ashamed!

Nine 483s is about normal for this industry. Definitely NOT unheard of. Usually due to the understaffing and overworking of plant personnel who are quota driven.

 

[anonymous]

Nine 483s is about normal for this industry. Definitely NOT unheard of. Usually due to the understaffing and overworking of plant personnel who are quota driven.

Seems to me this indicates a possible noncompliance with regulations, CFR 21, and a focus on fast production and profits. Definitely not good!

 

[anonymous]

Nine 483s is about normal for this industry. Definitely NOT unheard of. Usually due to the understaffing and overworking of plant personnel who are quota driven.

"About normal????????" I have never worked for a pharma company that had more than 1 483 observation. I have read thousands of reports and warning letters and only twice have I seen any company with 9 or more 483s and none of those were in the USA. You have no idea what you are talking about. 9 is outrageous and should result in a plant closure.

 

[anonymous]

If I am not mistaken, KBI Boulder makes biologics. Therefore, nine 483 observations is quite high. I might expect 1 or, perhaps, 2, but no more than that as biologics require strict GMP/GDP.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

Those must have been major GMP Violations. What Coherus product?

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

So is Coherus still doing business with KBI? You would think they would find a new CDMO.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

If this is true, then KBI may be losing many clients.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

Not surprising. I worked there a few years ago and management told us not to worry about GMP. We were told aseptic did not matter. Catching up to them finally.

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

What was Coherus' response to KBI? Suing? End of contract?

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

What were the GMP Violations? What did the FDA say about this?

 

[anonymous]

More failure in the form of Coherus drug that was rejected by FDA due to GMP violations at the KBI site.

Amazing! KBI must be a horrible company!