FDA 483 - Topiderm Inc. - March 07, 2025

Topiderm Inc. in Amityville, NY, was cited for significant deficiencies during an FDA inspection, primarily concerning manufacturing equipment and quality control procedures. The firm failed to qualify manufacturing equipment used for drug products distributed in the US market. Additionally, the quality control unit did not adhere to multiple written procedures, including those for customer complaint handling, change control, laboratory logbook documentation, and good documentation practices, with instances of overwritten data.