FDA 483 - Darmerica, LLC - March 18, 2025

Darmerica, LLC, an active pharmaceutical importer, repacker, and relabeler in Davie, FL, received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including releasing products without complete testing, failing to verify drug identity, inadequate complaint investigations, and poor supplier qualification. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance.