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.
Alexza CRL Followed 483 Citing Drug Storage, Training Lapses
- Post author:Sam
- Post published:April 8, 2016
- Post category:QMN Weekly Bulletin