FDA 483 - Cyclomedica Australia Pty Ltd - August 08, 2023

Cyclomedica Australia Pty Ltd received a Form 483 with four observations during an inspection of its combination drug and medical device manufacturing facility in Kingsgrove, New South Wales, Australia. The observations primarily concern deficiencies in environmental monitoring, management review attendance, release of non-conforming components, and outdated quality control documentation. These issues indicate a lack of robust quality system controls.