# FDA 483 - ROE DENTAL LAB INC - October 23, 2023

Source: https://www.globalkeysolutions.net/records/483/roe-dental-lab-inc/9a0a6b2e-6bc2-40db-9a11-ebf00144dff3

> FDA 483 for ROE DENTAL LAB INC on October 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ROE DENTAL LAB INC
- Inspection Date: 2023-10-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: ROE DENTAL LAB INC, a medical device manufacturer in Independence, OH, was inspected by the FDA from October 10-23, 2023. The inspection revealed significant deficiencies in their quality system, including inadequate validation of their dental abutment milling process, insufficient documentation of corrective and preventive actions, lack of established equipment calibration procedures, and failure to perform internal quality audits. These issues indicate a need for comprehensive improvements in their manufacturing and quality control processes.

## Related Documents

- [483 - 2022-10-11](https://www.globalkeysolutions.net/records/483/roe-dental-lab-inc/1f83f0c9-2a92-4805-9919-fddded058c9b)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/roe-dental-lab-inc/20faa43e-dff7-4e19-9cbc-635f3cf8983c

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