FDA 483 - CNMC Company, Inc. - February 12, 2026

An FDA inspection of CNMC Company, Inc., a manufacturer of radiation dosimeters in Nashville, TN, revealed that the firm failed to adequately maintain records of risk management activities. Specifically, the firm's risk assessment for its medical device did not sufficiently identify potential hazards to patients undergoing ionization radiation treatment. This indicates a deficiency in ensuring the safety and quality control of medical equipment.