Lannett Company, Inc. announced that the FDA recently completed a cGMP inspection of the company’s manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia: Darmantest Laboratory, the company’s pharmacokinetic subsidiary, and Firmplace, a stability laboratory with which the company has a strategic relationship. The inspections concluded with two minor 483 observations at the company’s facility in Philadelphia and zero observations at the laboratories in Armenia.
“At a time of particularly rigorous scrutiny by FDA, we achieved a trifecta of successful inspections at our facilities,” said Arthur Bedrosian, chief executive officer of Lannett. “Compliance with Current Good Manufacturing Practices (cGMP) provides confidence to our customers and, ultimately patients, that our products are manufactured under strict adherence to the highest level of quality standards. I commend our entire team for their dedication to regulatory excellence. Also, we are proud to have built and maintained a strong working relationship with FDA, especially with our local FDA Philadelphia District, to ensure that all of the medicines we produce are safe and effective.
“Passing inspection at our overseas stability and bio-study laboratories is an important milestone and paves the way for us to ramp up our product development efforts at these locations and reduce certain R&D costs going forward.”