FDA 483 - Aus Systems Pty Ltd - May 04, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from May 1-4, 2023, Aus Systems Pty Ltd, a manufacturer located in Allenby Gardens, South Australia, received a Form FDA-483 citing three observations related to its quality management system. The inspection highlighted deficiencies in the company's adherence to regulatory quality system requirements, as mandated by the Federal Food, Drug and Cosmetic Act.

Key issues included a lack of clearly defined control over suppliers, particularly concerning the management of underperforming vendors. The firm also demonstrated inadequate documentation of corrective and preventive action (CAPA) activities, specifically regarding the effectiveness check for Corrective Action Report #131. Furthermore, the inspection noted that individuals conducting quality audits had direct responsibility for the audited matters, indicating a failure to fully implement the independence requirement of the internal audit procedure. Aus Systems Pty Ltd has promised to address these observations, which require implementing robust corrective actions to ensure compliance with FDA regulations.