# FDA 483 - SALUDA MEDICAL PTY. LTD. - August 25, 2022

Source: https://www.keypedia.com/records/483/saluda-medical-pty-ltd/f6f38ba5-89a9-4f6f-91e2-fc7c3b19255b

> FDA 483 for SALUDA MEDICAL PTY. LTD. on August 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SALUDA MEDICAL PTY. LTD.
- Inspection Date: 2022-08-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SALUDA MEDICAL PTY. LTD. in Macquarie Park, Australia, was inspected by the FDA from August 22-25, 2022. The inspection revealed that the firm's procedures for ensuring equipment is routinely calibrated were not adequately established or implemented. This resulted in equipment being used past its calibration due date.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd