FDA 483 - Therametric Technologies, Inc. - September 11, 2014

An FDA inspection of THERAMETRIC TECHNOLOGIES, INC. in Noblesville, IN, revealed widespread deficiencies in their quality system for the FluoreCam caries detection device. The firm failed to establish or adequately implement procedures for critical areas including corrective and preventive actions, complaint handling, design controls, process validation, and overall quality management. These systemic issues indicate a significant lack of documented and controlled processes for medical device manufacturing.