AVEVA Drug Delivery Systems, Inc. – FDA 483, Aug 14, 2026

AVEVA Drug Delivery Systems, Inc. in Miramar, FL, a drug manufacturer, was inspected and cited for significant deficiencies across material, quality, and drug supply chain security systems. Observations included failures in component identity verification, inadequate quality control unit procedures such as late Field Alert Report submissions and improper material segregation, and a lack of systems to comply with DSCSA verification requirements. These issues indicate a moderate level of non-compliance with regulatory standards.