FDA 483 - Tonica Elektronik A/S - March 27, 2025

Tonica Elektronik A/S, a device manufacturer in Farum, Denmark, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in the firm's device history records and design validation processes. These issues specifically concerned the documentation of instructions for use and the confirmation of design changes for the MagVenture TMS Atlas Neuro Navigation system.