FDA 483 - Darmerica, LLC - July 18, 2019

Darmerica, LLC, an API repacker/relabeler in Casselberry, FL, was inspected by the FDA. The inspection revealed significant deficiencies in quality control, including a lack of OOS investigations for temperature excursions, inadequate supplier qualification and material release procedures, and unqualified/unvalidated equipment for API storage and transport. These issues indicate a severe lack of control over the quality and integrity of active pharmaceutical ingredients.