FDA 483 - Transdermal Cap Inc. - March 26, 2024

Transdermal Cap Inc. in Highland Heights, OH, a medical device manufacturer of LaserCap devices for hair regrowth, was cited with 11 observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including design history files, CAPA, non-conforming product control, and supplier management. These issues indicate a broad lack of adherence to established quality system procedures and regulatory requirements.