FDA 483 - AxioMed, LLC. - January 13, 2023

AxioMed, LLC. in Malden, MA, was inspected by the FDA from December 15, 2022, to January 13, 2023. The inspection revealed that the firm failed to submit annual progress reports for a significant risk device study to the FDA. Specifically, reports due in 2015, 2017, and 2019 were not submitted as required.