# FDA 483 - Gergens Orthodontic Lab, Inc. - March 30, 2023

Source: https://www.globalkeysolutions.net/records/483/gergens-orthodontic-lab-inc/a06c6445-bb30-4915-93ca-6bf6a701b151

> FDA 483 for Gergens Orthodontic Lab, Inc. on March 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gergens Orthodontic Lab, Inc.
- Inspection Date: 2023-03-30
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Gergens Orthodontic Lab, Inc., a medical device manufacturer in Phoenix, AZ, revealed a significant lapse in quality system management. The firm was cited for failing to perform quality audits, specifically noting that no internal audits had been conducted since 2019. This indicates a fundamental issue with the firm's quality assurance processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/gergens-orthodontic-lab-inc/589139e3-62a4-4aca-95af-0a3c18e74b0a

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face