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

During an FDA inspection from July 31 to September 7, 2018, medical device manufacturer Conformis, Inc. in Billerica, MA, received a Form FDA 483 outlining significant quality system deficiencies. The main violations centered on inadequate design change procedures, specifically failing to revalidate biocompatibility and sterility studies after raw material alterations for their knee replacement and repair implant systems, and not reverifying endotoxin testing methods for new formulations. The inspection also revealed insufficient documentation for process review and revalidation, particularly concerning bioburden acceptance criteria and sterilization parameters. Furthermore, Conformis failed to adequately document and approve process validation activities, including discontinuing critical temperature monitoring during revalidations without proper justification. Deficiencies extended to the corrective and preventive action (CAPA) system, with a failure to initiate actions for sterilization cycle failures and a systemic delay in documenting numerous customer complaints, some involving serious patient outcomes like revision surgeries. Inadequate vendor controls for critical services, such as bioburden testing and sterilization equipment calibration, were also cited. Conformis, Inc. is required to provide a comprehensive response to the FDA detailing corrective and preventive actions to address these observations and ensure compliance with medical device quality system regulations.