FDA 483 - Darmerica, LLC - March 11, 2022

Darmerica, LLC, a human and animal API repacker/relabeler in Casselberry, Florida, was cited for significant deficiencies across its quality system. Observations included inadequate supplier qualification and COA verification, improper storage of APIs, deficient controls for analytical equipment, failure to follow annual product review procedures, and inadequate cleaning procedures. These issues indicate a lack of robust quality control and adherence to established protocols.