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

An FDA inspection of Aus Systems Pty Ltd, a manufacturer in Allenby Gardens, South Australia, revealed three observations related to their quality system. Deficiencies included inadequate control over suppliers, insufficient documentation of corrective and preventive actions, and a lack of independence in quality audits. These issues indicate general weaknesses in the firm's quality management processes.