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

Source: https://www.keypedia.com/records/483/saluda-medical-pty-ltd/5bdabd2c-d2f9-428c-b93d-e857a66458c8

> FDA 483 for Saluda Medical PTY LTD on June 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saluda Medical PTY LTD
- Inspection Date: 2019-06-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/saluda-medical-pty-ltd/a6b56593-ddb1-46df-8080-71e9f11e90da

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