FDA 483 - DERMDOX CENTERS FOR DERMATOLOGY - January 21, 2021

DERMDOX CENTERS FOR DERMATOLOGY in Sugarloaf, PA, was cited for significant deficiencies in conducting clinical investigations and maintaining accurate records. The inspection revealed issues with subject enrollment, including dual participation in studies and inadequate documentation, as well as uncalibrated equipment used for critical measurements and sample processing. Additionally, the firm failed to ensure consistency between source and electronic case report forms regarding investigational product dosing.