FDA 483 - Cyclomedica Australia Pty Ltd - April 06, 2021

An FDA inspection of Cyclomedica Australia Pty Ltd in Kingsgrove, New South Wales, revealed significant deficiencies across its manufacturing processes for combination drug/device, drug product, and drug substance. The firm failed to adequately qualify equipment, validate test methods, and establish robust process controls. Additionally, issues were noted in data integrity, supplier management, material specifications, and personnel training, indicating a broad lack of adherence to quality system requirements.