# FDA 483 - Acuity Surgical Devices, LLC - May 20, 2019

Source: https://www.globalkeysolutions.net/records/483/acuity-surgical-devices-llc/58249cd0-186f-4d6f-86eb-902d7ca0cf4c

> FDA 483 for Acuity Surgical Devices, LLC on May 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acuity Surgical Devices, LLC
- Inspection Date: 2019-05-20
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Reflexy Surgical Devices, LLC in Irving, TX, identified significant deficiencies in the firm's quality system. Observations included a lack of internal audits for three consecutive years, inadequate documentation of personnel training, and the absence of established procedures for equipment calibration. These issues indicate a failure to ensure compliance with quality system procedures and proper control over critical manufacturing processes.

## Related Documents

- [483 - 2025-01-27](https://www.globalkeysolutions.net/records/483/acuity-surgical-devices-llc/3fc69532-35da-418d-b03e-971deabd0829)

## Related Officers

- [Jeremy L Stukes](https://www.globalkeysolutions.net/people/jeremy-l-stukes/03812740-3c4d-4b11-9da3-44b7a03d72b1)

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

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