# FDA 483 - Sunnex, LLC - July 03, 2019

Source: https://www.keypedia.com/records/483/sunnex-llc/302ed72b-3461-42b4-9f5c-8035735c3805

> FDA 483 for Sunnex, LLC on July 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunnex, LLC
- Inspection Date: 2019-07-03
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Sunnex, LLC, a medical device manufacturer in Charlotte, NC, revealed numerous significant deficiencies in its quality system. The firm failed to adequately establish and follow procedures for design validation, design verification, process validation, complaint handling, and documentation. These issues indicate a broad lack of adherence to medical device regulations, impacting the quality and safety of their medical lights.

## Related Documents

- [483 - 2022-02-18](https://www.keypedia.com/records/483/sunnex-llc/b17b94c3-ac91-41b3-b57f-0b8b3cbbfe28)

## 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