Next Breath finishes successful FDA inspection
The FDA inspected the company's laboratory facility on October 15 in Baltimore to make sure it was in compliance with the principles and guidelines of good manufacturing practices. The inspection included the facility's quality system geared at contract research and commercial batch release of drug products.
Next Breath received a successful accreditation earlier in 2012 by the World Health Organization as a testing facility for nasal spray vaccine drug delivery.
"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," Julie Suman, the president of Next Breath, said. "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."
Next Breath, a member of the AptarGroup, is a contract services organization for biotech, pharmaceutical and medical device companies to bring nasal and inhalation projects to market. The company's services include analytical testing and pre-clinical formulation in the attempt to submit products to regulatory agencies.