Maryland-based CRO Next Breath, which specializes in OINDP analysis, has announced that an October 15, 2012 GMP inspection by the FDA found the company’s Baltimore facility to be compliant. The inspection resulted in no Form 483 and no observations.
Earlier this year, the World Health Organization (WHO) accredited Next Breath as a testing facility for nasal spray vaccine drug delivery.
Next Breath President Julie Suman said, “We are very pleased with the results of the US FDA GMP inspection, which confirms Next Breath’s commitment to meeting and exceeding the highest quality standards. We work diligently to maintain regulatory standards and we have once again demonstrated our ability to sustain and continuously improve quality systems within our organization.”