FDA Cites Subpar Validations, Risk Analysis at Florida Facility
The FDA has cited Anodyne Therapy for failing to send reports to the agency about several patients who suffered radiation burns linked to the firm’s infrared light therapy devices.
An inspection of the firm’s Oldsmar, Fla., facility found that the design validation for the devices did not focus on the patient population to demonstrate the acceptability of the temperature.
The design risk analysis didn’t include an evaluation of all hazards that were “reasonably known,” such as a severity/probability rating for burns. At least three patients suffered burns after using the devices, and the firm failed to report the adverse events to the FDA, the inspection report said.