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Merck Boulder

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

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  1. 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!
     
  2. 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.
     
  3. 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.
     
  4. anonymous

    anonymous Guest

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

    anonymous Guest


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

    anonymous Guest


    If this is true, then KBI may be losing many clients.
     
  7. 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.
     
  8. anonymous

    anonymous Guest

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

    anonymous Guest

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

    anonymous Guest

    Amazing! KBI must be a horrible company!
     
  11. anonymous

    anonymous Guest


    How did management react?
     
  12. anonymous

    anonymous Guest

    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
     
  13. anonymous

    anonymous Guest

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

    anonymous Guest

    When did this happen?
     
  15. anonymous

    anonymous Guest

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