FDA 483 - ONC Solutions Incorporated - September 10, 2019

ONC Solutions Incorporated, a medical device manufacturer in Acton, MA, received a Form 483 with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate controls for purchased products, environmental conditions, internal audits, and non-conforming materials. Two of the observations, concerning purchased product control and non-conforming material, were repeats from a previous inspection, highlighting persistent issues with the X-Mark Fiducial Marker, a Class II medical device.