FDA warns Bris­tol My­ers Squibb for im­prop­er­ly in­ves­ti­gat­ing con­t­a­m­i­na­tion at site that makes Abrax­ane

Fol­low­ing a 10-day in­spec­tion ear­li­er this year, the FDA has sent a warn­ing let­ter with sev­er­al point­ed ques­tions to a Phoenix-based site, which is run by Abrax­is Bio­science and owned by Bris­tol My­ers Squibb.

The warn­ing let­ter to BMS CEO Gio­van­ni Caforio said the site did not ef­fec­tive­ly im­ple­ment cor­rec­tive ac­tions and pre­ven­tive ac­tions or ad­e­quate­ly con­trol its asep­tic pro­cess­ing line and man­u­fac­tur­ing op­er­a­tions.

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