# Orion Medical Solutions, LLC – FDA 483, May 21, 2026

Source: https://www.keypedia.com/records/483/orion-medical-solutions-llc/2ae6ba19-0a1f-4e5f-a43d-5e1ba88ef030

> FDA 483 for Orion Medical Solutions, LLC on May 21, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orion Medical Solutions, LLC
- Inspection Date: 2026-05-21
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Orion Medical Solutions, LLC, an initial importer and complaint file establishment in Watkinsville, GA, was cited for multiple deficiencies in its quality management system during an FDA inspection. The observations primarily concern inadequate written procedures for complaint handling, corrective actions, document control, and traceability, as well as a lack of quality agreements with suppliers and proper purchasing controls for Class III pre-filled syringe products. These issues indicate a systemic lack of documented and implemented controls essential for medical device quality.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/orion-medical-solutions-llc/6857a412-76e7-491a-a133-8a4a115693aa

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