# FDA 483 - SMITHWORKS, INC. - April 04, 2025

Source: https://www.globalkeysolutions.net/records/483/smithworks-inc/71831bba-e07a-4a3a-aa3a-537629e2c772

> FDA 483 for SMITHWORKS, INC. on April 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMITHWORKS, INC.
- Inspection Date: 2025-04-04
- Product Type: device
- Office Name: Dallas District Office
- Summary: SMITHWORKS, INC. in Lindale, TX, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for design changes, specifically regarding the validation of testing procedure modifications for IV Fluid Warmers. Additionally, they lacked proper procedures for controlling nonconforming products, including review, segregation, disposition, and ensuring sufficient data for investigations and corrective actions.

## Related Documents

- [483 - 2023-08-29](https://www.globalkeysolutions.net/records/483/smithworks-inc/5bbc6cfa-88a4-4315-b57c-0b84864dccd9)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/smithworks-inc/b922c929-1342-4ea7-a4dc-a042c0901aab

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