# FDA 483 - Dentonics, Inc - April 28, 2022

Source: https://www.keypedia.com/records/483/dentonics-inc/3238a810-9bf0-4220-96e4-d6b7364eb4d8

> FDA 483 for Dentonics, Inc on April 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentonics, Inc
- Inspection Date: 2022-04-28
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Dentonics, Inc. in Monroe, NC, was inspected from April 20-28, 2022, and received nine observations related to significant deficiencies in their quality system. Key issues include a lack of process validation for Glass Ionomer Luting Cement, inadequate purchasing controls for suppliers and consultants, and failures in maintaining device master records, labeling procedures, equipment calibration, and document and distribution controls. These findings indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2024-09-19](https://www.keypedia.com/records/483/dentonics-inc/2db1f9cd-0ea2-459a-ba1c-8c01702b6331)

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/dentonics-inc/d037b793-0be4-46a5-9441-c88837ec8254

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