Merck Boulder

Discussion in 'Merck' started by anonymous, Jun 25, 2017 at 2:08 AM.

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  1. anonymous

    anonymous Guest


    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.
     

  2. anonymous

    anonymous Guest

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

    anonymous Guest

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

    anonymous Guest

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

    anonymous Guest

    Getting what they can before the Boulder site is closed.
     
  6. anonymous

    anonymous Guest

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

    anonymous Guest


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

    anonymous Guest

    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!
     
  9. anonymous

    anonymous Guest


    Which Coherus drug was it? What GMP Violations?
     
  10. anonymous

    anonymous Guest

    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.
     
  11. anonymous

    anonymous Guest

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

    anonymous Guest

    "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.
     
  13. anonymous

    anonymous Guest

    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.
     
  14. anonymous

    anonymous Guest

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

    anonymous Guest


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

    anonymous Guest


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

    anonymous Guest

    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.
     
  18. anonymous

    anonymous Guest

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

    anonymous Guest

    What were the GMP Violations? What did the FDA say about this?
     
  20. anonymous

    anonymous Guest

    Amazing! KBI must be a horrible company!