# FDA 483 - Trewavis Surgical Instruments Pty Ltd. - August 17, 2022

Source: https://www.keypedia.com/records/483/trewavis-surgical-instruments-pty-ltd/f991268e-8ee5-4123-8b45-df7664f29b9a

> FDA 483 for Trewavis Surgical Instruments Pty Ltd. on August 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trewavis Surgical Instruments Pty Ltd.
- Inspection Date: 2022-08-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Trewavis Surgical Instruments Pty Ltd. in Bayswater, Australia, received a Form FDA 483 following an inspection. The inspection revealed two significant issues related to the firm's quality system, specifically concerning the inadequate implementation of procedures for finished device acceptance and equipment maintenance. These observations indicate deficiencies in ensuring product quality and operational control.

## Related Officers

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

Company: https://www.keypedia.com/companies/trewavis-surgical-instruments-pty-ltd/2985bcc9-0ba0-42ba-876b-e49655f4a3eb

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