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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: rkrw who wrote (49395)1/20/2019 12:39:28 PM
From: weatherproof5 Recommendations

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alwayshope
captcobra1
drtom1234
EMU2
patlawche11

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"Pfizer says it has voluntarily paused production at a manufacturing facility in India, afterreceiving a US FDA Form 483 with 11 observations."


"Amgen’s Longmont, Colo., and Boulder, Colo., facilities received Form 483s for observations that range from inadequate investigations into quality failures to no validation of manufacturing processes"

"Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris"

"Another Johnson & Johnson drug plant gets flagged"
"Merck and Company received a Warning Letter from the US Food and Drug Administration about its West Point, Pennsylvania, facility. FDA cited Merck's failure to address concerns raised in an earlier Form 483 about the facility"

Do you want that I should keep going? Oy vey!
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