Merck Boulder

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anonymous said:
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.[/I
Amazing that you could even figure out how to use a computer...a DOZEN more 483's really, wow...that would mean a dozen or more visits as only one 483 can be issued per inspection...I think you are trying to refer to the number of OBSERVATIONS in a 483 as opposed to the number of 483s, but its not easy to decipher...please, enlighten us with the references you used for "normal and accepted" also....I love when stupid people try to sound intelligent!
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Dear Janitor, yes 9 483 observations in December 2016. A record number! The FDA came back in February 2017 and issued more than a dozen observations and made KBI come clean about what they were hiding in December. A KBI employee turned the company in for their failure to conduct proper GMP/GDP. Bet you did not know that little one! Look on glass door.com for all the hideous reviews of KBI-Boulder. You do not know much for working at KBI! Perhaps you should ask questions and use the power of observation if possible. Everyone else at KBI knows this info. and who turned KBI in.
 






I know the FDA came back numerous times in 2017 and we were worried about a plant shutdown. Management's fault they did not take the issues seriously. Unfortunate how the few professionals making changes here have ben forced out.
 












anonymous said:
Dear Janitor, yes 9 483 observations in December 2016. A record number! The FDA came back in February 2017 and issued more than a dozen observations and made KBI come clean about what they were hiding in December. A KBI employee turned the company in for their failure to conduct proper GMP/GDP. Bet you did not know that little one! Look on glass door.com for all the hideous reviews of KBI-Boulder. You do not know much for working at KBI! Perhaps you should ask questions and use the power of observation if possible. Everyone else at KBI knows this info. and who turned KBI in.
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a record number, really? Wow, you must have really done your research on that, this must be a regulatory expert speaking! So tell us , what comes next for the site? Please, educate us further. I get a kick out of this person spouting off about an area they obviously know very little about. A disgruntled current or ex employee I suspect, probably working hard to finish their GED
 






anonymous said:
a record number, really? Wow, you must have really done your research on that, this must be a regulatory expert speaking! So tell us , what comes next for the site? Please, educate us further. I get a kick out of this person spouting off about an area they obviously know very little about. A disgruntled current or ex employee I suspect, probably working hard to finish their GED
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You have only a foul mouth and rudeness. You must be about 22. I think you could learn from the professional KBI employees posting on Cafepharma.
 


















Back to the Original question. In the last 1 1/2 years, KBI has not produced anything for commercial markets...all development. Coherus 1701 was supposed to go commercial, but that may not be for several years.
 






anonymous said:
You have only a foul mouth and rudeness. You must be about 22. I think you could learn from the professional KBI employees posting on Cafepharma.
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foul mouthed? I speak the truth, don't need curse words. I have no horse in this game, admit I do not work at the KBI site, never said I did. What I do know is that the person spouting off about the regulatory issues at KNI has no clue what they are talking about, anyone with limited knowledge of reg agency inspections can see that. The site certainly has issues, but nothing unprecedented as the posters so crudely suggests. Nothing more than a disgruntled current hourly employee, trying to stir the pot but failing,
 






anonymous said:
foul mouthed? I speak the truth, don't need curse words. I have no horse in this game, admit I do not work at the KBI site, never said I did. What I do know is that the person spouting off about the regulatory issues at KNI has no clue what they are talking about, anyone with limited knowledge of reg agency inspections can see that. The site certainly has issues, but nothing unprecedented as the posters so crudely suggests. Nothing more than a disgruntled current hourly employee, trying to stir the pot but failing,
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Troll. Thinks they know more about KBI than the employees. Sad person!
 






I have no horse in this game...not cat...nor elephant. I was bullied as a child by my cat and became a Troll. I know nothing but I like to pretend. I have no life so I Comment on companies I know nothing about. Sorry! The Troll.
 










































anonymous said:
Signs of a Troll: arrogance, immaturity, stupidity, budding in to other people's business, and the won't go away. This Troll fits all those signs.
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By the way it's "butting", not "budding"..."budding" would apply to a plant...one would think a regulatory expert such as yourself would know the difference!
 












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