# FDA 483 - Turnco Tool & Instrument, Inc. - February 11, 2026

Source: https://www.globalkeysolutions.net/records/483/turnco-tool-instrument-inc/9fc8075f-6c64-4561-8599-6883c725d185

> FDA 483 for Turnco Tool & Instrument, Inc. on February 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Turnco Tool & Instrument, Inc.
- Inspection Date: 2026-02-11
- Product Type: device
- Office Name: Dallas District Office
- Summary: Turnco Tool & Instrument, Inc., a contract manufacturer in Georgetown, TX, was cited for significant deficiencies in its quality system. The inspection revealed a lack of documented risk management processes for critical manufacturing steps like deburring and for undersized devices, despite receiving customer complaints. Additionally, the firm lacked documented procedures and acceptance criteria for controlling the deburring process for Class II devices, raising concerns about product conformity and patient safety.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/turnco-tool-instrument-inc/5eed2374-15e8-4207-8109-2711e88c9035)

## Related Officers

- [Elizabeth A. Krolczyk](https://www.globalkeysolutions.net/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.globalkeysolutions.net/companies/turnco-tool-instrument-inc/ba41aa57-dcb6-4948-99af-82c2b0e3f78f

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9