# FDA 483 - Acuity Surgical Devices, LLC - January 27, 2025

Source: https://www.keypedia.com/records/483/acuity-surgical-devices-llc/3fc69532-35da-418d-b03e-971deabd0829

> FDA 483 for Acuity Surgical Devices, LLC on January 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acuity Surgical Devices, LLC
- Inspection Date: 2025-01-27
- Product Type: device
- Office Name: Dallas District Office
- Summary: Acuity Surgical Devices, LLC, a medical device manufacturer in Irving, TX, was inspected by the FDA from January 21-27, 2025. The inspection revealed significant deficiencies in supplier management, including incomplete supplier evaluations and missing documentation. Additionally, the firm's employee training procedures were found to be inadequate, with issues in ensuring employee understanding of SOPs and addressing overdue trainings.

## Related Documents

- [483 - 2019-05-20](https://www.keypedia.com/records/483/acuity-surgical-devices-llc/58249cd0-186f-4d6f-86eb-902d7ca0cf4c)

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/acuity-surgical-devices-llc/7a43f0bd-5814-46dc-b8f4-0b7cc6b2b727

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