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

During an FDA inspection conducted from June 2-6, 2025, the firm received a Form FDA-483, identifying multiple compliance issues regarding its LaserCap Family of Lasers. The primary concern was the inadequate evaluation and investigation of device complaints, particularly in determining reportability under Medical Device Reporting (MDR) regulations. The firm failed to obtain sufficient information to justify non-reportability for incidents such as scalp burns, blurry eyes, headaches, and devices shorting or smoking. This critical observation was a repeat from a previous FDA inspection.

Additional findings included the firm's failure to submit annual reports for its Class IIa/3R LaserCap devices, which have been distributed since July 2015. Furthermore, the company did not include the required class designation and warning logotype label in its sales brochures for these laser products. Lastly, the identification labels on the LaserCap devices lacked the properly formatted month and year of manufacture. The firm has indicated its commitment to correct all identified observations, acknowledging its responsibility to resolve these non-compliance issues and ensure adherence to federal medical device regulations.