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

An FDA inspection of Aveva Drug Delivery Systems Inc., conducted from July 8-11, 2025, identified significant deficiencies in its quality system and manufacturing controls for sterile drug products. Key issues included the quality control unit's failure to approve or reject contract-manufactured products and a lack of scientific justification for commercial manufacturing readiness. Specific violations involved incomplete Master Batch Records, faulty media fill simulations using incorrect mould sizes and resulting in leaking vials, and the absence of cleaning validations for manufacturing equipment. The firm also failed to complete or adequately document analytical method verifications and transfers. Gowning procedures for sterile manufacturing were deemed inadequate, lacking proper qualification for equipment and protocols for reuse and integrity testing of garments and gloves.

Further observations highlighted deficient laboratory controls, particularly an inadequate microbiological procedure for examining microbial plates, which lacked detailed instructions for colony counting and analyst verification. The quality control unit also failed to adhere to written procedures for supplier qualification, releasing materials without complete testing, and maintained a deficient SOP for chromatography peak integration. Critically, a written procedure for 100% visual inspection of finished aseptically processed sterile drug products was absent. These findings indicate a lack of adherence to Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. Aveva Drug Delivery Systems Inc. is required to implement comprehensive corrective and preventive actions to address these observations and ensure compliance.