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Home » Alexza CRL Followed 483 Citing Drug Storage, Training Lapses
Alexza CRL Followed 483 Citing Drug Storage, Training Lapses
June 4, 2012
Concerns about inadequate drug storage and quality training at Alexza’s Mountain View, Calif., facility were cited by FDA investigators just weeks before the company received a complete response letter (CRL) rejecting its combination product for agitation drug Adasuve, an FDA Form 483 states.