# FDA 483 - 360 Imaging LLC - March 03, 2022

Source: https://www.keypedia.com/records/483/360-imaging-llc/1a7b9d4d-366f-4531-9665-b72f70412954

> FDA 483 for 360 Imaging LLC on March 03, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 360 Imaging LLC
- Inspection Date: 2022-03-03
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 360 Imaging LLC, a manufacturer in Atlanta, GA, received a Form FDA 483 with seven observations primarily concerning significant deficiencies in their quality system. Key issues include inadequate management review, CAPA, complaint handling, acceptance activities, training, and document control procedures. The firm also failed to establish a design history file for its Class II dental planning software.

## Related Officers

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

Company: https://www.keypedia.com/companies/360-imaging-llc/29354c16-6eeb-4522-ad5a-d4cd7c268c62

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