FDA 483 - Saluda Medical PTY LTD - June 06, 2019

Saluda Medical PTY LTD, a medical device manufacturer in Artarmon, Australia, was inspected by the FDA from June 3-6, 2019. The inspection revealed significant deficiencies in quality system procedures, including issues with software validation, corrective and preventive actions, non-conforming product control, and device master record maintenance. These observations indicate a need for improved adherence to regulatory requirements for medical device manufacturing.