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The QMN Weekly Bulletin
June 8, 2012 | Vol. 4 No. 23
Alexza CRL Followed 483 Citing Drug Storage, Training Lapses
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.
Those issues, cited during a second preapproval inspection late last year, have since been corrected, Alexza CEO Thomas King said. The company responded to the Form 483 twice, in January and in March, before receiving the CRL for Adasuve (loxapine) last month, he noted.
At the time of the inspection, there was no approved written procedure describing the role quality assurance personnel have for storage, handling, sampling and testing of purified water produced at the plant, the form states.
Investigators also pointed out that complaint handling instruction was not required as part of the company’s quality assurance training curriculum. Documentation of such training was not available, the FDA said.
While there are more than 20 references to training within the FDA’s good manufacturing practice (GMP) regulations, the vagueness of the requirements is a constant source of confusion for companies, their training officers and their employees. When companies’ employees are properly trained, enforcement actions like 483s and warning letters are easier to avoid.
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