FDA 483 - Transdermal Cap Inc. - June 06, 2025

Transdermal Cap Inc. in Highland Heights, OH, a medical device manufacturer, was inspected by the FDA, revealing significant quality system deficiencies. The firm failed to adequately evaluate and investigate complaints for Medical Device Reporting (MDR) purposes, a repeat observation from a previous inspection. Additionally, the company did not submit required annual reports for its laser products and had labeling issues concerning warning logotypes in brochures and manufacturing dates on identification labels.