FDA 483 - Turncare, Inc - December 11, 2024

During an inspection from November to December 2024, Turncare, Inc. of Pompton Plains, NJ, was cited for failing to report violations of the FD&C Act involving their Guardian System 2 Controllers, which might present a risk to health. Specifically, the firm did not report or justify not reporting software malfunctions that caused devices to fail in delivering intended therapy. This indicates a significant lapse in their adverse event reporting and recall procedures.