FDA 483 - Aveva Drug Delivery Systems, Inc. - July 11, 2025

An FDA inspection of Aveva Drug Delivery Systems Inc in Tamarac, FL, revealed significant deficiencies in their quality control unit, particularly concerning the approval of drug products and readiness for commercial manufacturing of a sterile drug product. The inspection also identified inadequate laboratory controls, including microbiological procedures, and a deficient supplier qualification program. These issues indicate a lack of robust quality systems necessary for sterile drug manufacturing.