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

Source: https://www.keypedia.com/records/483/saluda-medical-pty-ltd/ee84d0b0-db9d-433d-a6d7-e2555caacc60

> FDA 483 for SALUDA MEDICAL PTY. LTD. on May 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SALUDA MEDICAL PTY. LTD.
- Inspection Date: 2025-05-16
- Product Type: device
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2022-08-25](https://www.keypedia.com/records/483/saluda-medical-pty-ltd/f6f38ba5-89a9-4f6f-91e2-fc7c3b19255b)

## Related Officers

- [Marvin A. Marenco](https://www.keypedia.com/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

Company: https://www.keypedia.com/companies/saluda-medical-pty-ltd/33daea76-4307-4424-ae70-6a4f0984f8c6

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917