# FDA 483 - Signature Orthopedics Pty Limited - July 05, 2018

Source: https://www.globalkeysolutions.net/records/483/signature-orthopedics-pty-limited/6716938b-2573-4a71-a003-b2f0d0824f8d

> FDA 483 for Signature Orthopedics Pty Limited on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signature Orthopedics Pty Limited
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Signature Orthopedics Pty Limited, a medical device manufacturer in Sydney, Australia, received a Form FDA-483 with three observations. The inspection revealed deficiencies in establishing adequate procedures for corrective and preventive actions, evaluating the impact of failed test equipment, and conducting management reviews. These issues indicate a need for improved quality system controls.

## Related Documents

- [483 - 2018-07-02](https://www.globalkeysolutions.net/records/483/signature-orthopedics-pty-limited/64f4a136-873e-4927-aa70-794baa900d81)

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/signature-orthopedics-pty-limited/684f8207-f340-40aa-9137-9f618a93cc92

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