# FDA 483 - Unite Medical LLC - April 16, 2025

Source: https://www.keypedia.com/records/483/unite-medical-llc/5c4c3c82-d5b8-47c5-a698-658655800f19

> FDA 483 for Unite Medical LLC on April 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unite Medical LLC
- Inspection Date: 2025-04-16
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Unite Medical LLC, a medical device manufacturer in Lithia Springs, GA, revealed significant deficiencies in their quality system. The firm failed to establish and implement essential procedures for complaint handling, supplier control, overall quality system management including audits, design control, and nonconforming product, as well as corrective and preventive actions. Additionally, their Medical Device Reporting (MDR) procedures were not properly implemented with required approval signatures and dates.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/unite-medical-llc/f71463e6-d8e2-4126-b926-3fb305698fc8

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