# FDA 483 - Sunnex, LLC - February 18, 2022

Source: https://www.keypedia.com/records/483/sunnex-llc/b17b94c3-ac91-41b3-b57f-0b8b3cbbfe28

> FDA 483 for Sunnex, LLC on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunnex, LLC
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Sunnex, LLC, a manufacturer of surgical light devices in Charlotte, NC, received an FDA Form 483 with 11 observations, many of which were repeats from a previous inspection. The observations primarily concern significant deficiencies in design controls, including validation, verification, transfer, and planning, as well as inadequate process validation, complaint handling, training, and document control. The firm also failed to properly analyze service reports and maintain complete device history records.

## Related Documents

- [483 - 2019-07-03](https://www.keypedia.com/records/483/sunnex-llc/302ed72b-3461-42b4-9f5c-8035735c3805)

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/sunnex-llc/8a909b31-6bcb-4a15-9c5e-c1f91bb4f858

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7