# FDA 483 - Dental Choice Holdings Llc - April 26, 2022

Source: https://www.keypedia.com/records/483/dental-choice-holdings-llc/4fd22c76-5376-4e5e-9887-624a780c4d86

> FDA 483 for Dental Choice Holdings Llc on April 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Choice Holdings Llc
- Inspection Date: 2022-04-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Dental Choice Holding Llc in Louisville, KY, revealed two significant observations. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, with no documented investigations for customer service records. Additionally, procedures for acceptance activities and documentation of device specifications prior to commercial release were not adequately established.

## Related Officers

- [Shannon A. Gregory](https://www.keypedia.com/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.keypedia.com/companies/dental-choice-holdings-llc/4df77d55-bf43-4bb6-974b-407e21ad53c3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22