FDA 483 - Conformis, Inc. - September 07, 2018

An FDA inspection of Conformis, Inc., a medical device manufacturer in Billerica, MA, revealed significant deficiencies in its quality system. The firm failed to adequately establish and follow procedures for design changes, process validation, corrective and preventive actions, vendor controls, and complaint handling. These issues indicate a systemic breakdown in ensuring the quality and safety of their Knee Replacement and Repair Implant Systems.