483
Aus Systems Pty LtdFDA 483 - Aus Systems Pty Ltd - May 04, 2023
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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.
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ID · 281bb930-da9d-44f2-b698-4c9c7aa6d577