VIRTUS PHARMACEUTICALS LLC. – FDA 483, Feb 1, 2018

An FDA inspection of VIRTUS PHARMACEUTICALS LLC. in Newtown, PA, revealed significant deficiencies in their pharmacovigilance system. The firm failed to establish written procedures for handling adverse drug experiences and repeatedly submitted periodic adverse drug experience reports (PADERs) late or not at all for multiple products. These issues indicate a systemic failure to comply with regulatory requirements for post-marketing safety surveillance.