FDA 483 - SALUDA MEDICAL PTY. LTD. - May 16, 2025

Saluda Medical Pty. Ltd. in Macquarie Park, Australia, was cited for three significant issues during an FDA inspection. These included failures in environmental control (un-certified cleanroom), inadequate production processes for device conformity, and delayed submission of Medical Device Reports (MDRs). The findings indicate a moderate level of non-compliance with quality system requirements for medical device manufacturing.