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 its quality control unit and laboratory operations. The firm lacked adequate scientific justification for commercial manufacturing of sterile drug products, including issues with master batch records, aseptic process simulations, cleaning validation, and analytical method verification. Additionally, the inspection found inadequate microbiological procedures and a deficient supplier qualification program, indicating a serious lack of control over critical manufacturing and testing processes.