# FDA 483 - Green Dental Lab - June 13, 2023

Source: https://www.keypedia.com/records/483/green-dental-lab/4b028d72-f31a-4a3d-9090-db234108d9d1

> FDA 483 for Green Dental Lab on June 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Green Dental Lab
- Inspection Date: 2023-06-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Green Dental Lab, a contract manufacturer in Heber Springs, AR, was cited for two observations during an FDA inspection. The firm failed to adequately review and evaluate customer complaints to determine if an investigation was necessary, and did not maintain proper records for decisions not to investigate. Additionally, procedures for controlling nonconforming products were not adequately established, as Product Nonconforming Reports were not generated for identified nonconformances related to their Class II EMA anti-snoring device.

## Related Officers

- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/green-dental-lab/420a479b-1703-4457-b366-aabf97e6791d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab