# FDA 483 - Wexler Surgical, Inc. - July 30, 2025

Source: https://www.globalkeysolutions.net/records/483/wexler-surgical-inc/874838fb-e975-44db-a0a1-69997bca2415

> FDA 483 for Wexler Surgical, Inc. on July 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wexler Surgical, Inc.
- Inspection Date: 2025-07-30
- Product Type: device
- Office Name: Dallas District Office
- Summary: Wexler Surgical, Inc. in Houston, TX, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, and design control and validation processes. These issues indicate a lack of adherence to established procedures and a failure to adequately ensure product quality and safety.

## Related Documents

- [483 - 2022-11-02](https://www.globalkeysolutions.net/records/483/wexler-surgical-inc/5769c926-398b-486f-8571-805fe98d1bd0)

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/wexler-surgical-inc/fe4d3dac-4ac8-4a8a-b0b3-017be6a22871

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