# FDA 483 - Koning Corporation - July 21, 2025

Source: https://www.keypedia.com/records/483/koning-corporation/8d098a57-1257-4c21-b7a6-a4b9839059b4

> FDA 483 for Koning Corporation on July 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Koning Corporation
- Inspection Date: 2025-07-21
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Koning Corporation in Norcross, GA, a manufacturer of Class III medical devices, revealed two significant observations. The firm failed to ensure its Koning Breast CT device labels bore a Unique Device Identifier (UDI) and did not provide the required device information to the Global Unique Device Identification Database (GUDID). These issues indicate non-compliance with medical device identification and registration regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/koning-corporation/b5b7451a-7cf7-4713-91ec-1987fdda610e

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