FDA 483 - Transdermal Cap Inc. - June 06, 2025
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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.
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ID · 8cd9107f-8aeb-4eb7-b4ad-fd79e665cb7a