# FDA 483 - SMITHWORKS, INC. - August 29, 2023

Source: https://www.keypedia.com/records/483/smithworks-inc/5bbc6cfa-88a4-4315-b57c-0b84864dccd9

> FDA 483 for SMITHWORKS, INC. on August 29, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMITHWORKS, INC.
- Inspection Date: 2023-08-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: SMITHWORKS, INC., a medical device manufacturer in Lindale, TX, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including failures to maintain device master records, establish procedures for design changes, acceptance activities, nonconforming product control, complaint handling, quality audits, and corrective and preventive actions. Additionally, the firm lacked written Medical Device Reporting (MDR) procedures, indicating a broad lack of fundamental quality system controls.

## Related Documents

- [483 - 2025-04-04](https://www.keypedia.com/records/483/smithworks-inc/71831bba-e07a-4a3a-aa3a-537629e2c772)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab