FDA 483 - Chamberlain Technologies LLC - May 09, 2025

An FDA inspection of Chamberlain Technologies LLC in Deer Park, IL, revealed that the firm failed to report a correction or removal of Class 2 medical devices to the FDA. The company incorrectly classified the action as a stock recovery, even though affected devices had been distributed and one was implanted in a patient, and its risk assessment for not reporting was inconsistent.