FDA 483 - Conformis Inc. - September 20, 2019

Conformis Inc., a medical device manufacturer in Wilmington, MA, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate process controls for sterilization, insufficient testing of incoming sterilization agents, non-compliance with clean room gowning procedures, and improper storage of labels leading to potential mix-ups. These issues indicate a lack of robust controls to ensure product quality and prevent contamination.