# FDA 483 - Gergens Orthodontic Lab - October 24, 2025

Source: https://www.keypedia.com/records/483/gergens-orthodontic-lab/52af221b-05f4-4e02-a3ae-1bb0a001e5e4

> FDA 483 for Gergens Orthodontic Lab on October 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gergens Orthodontic Lab
- Inspection Date: 2025-10-24
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Gergens Orthodontic Lab in Dunlap, IL, revealed five significant observations, including two repeat findings, indicating serious deficiencies in their quality system. The firm failed to adequately establish complaint handling procedures, conduct required management reviews, and properly document design validation for their Class II medical devices. Additionally, the company did not comply with Unique Device Identification (UDI) requirements, including database registration and proper device labeling.

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/gergens-orthodontic-lab/f3f63f6f-fe4f-4276-96c9-9c3d9b4c301a

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669