Conformis, Inc. – FDA 483, Mar 9, 2023

Conformis, Inc. in Billerica, MA, a specification developer, received a Form FDA 483 with four observations highlighting significant deficiencies in their quality system. Issues included inadequate procedures for corrective and preventive actions, design input controls, and complaint handling, leading to unaddressed systemic problems and incomplete investigations. The firm also failed to ensure timely complaint closures and proper MDR filing.