# FDA 483 - ROE DENTAL LAB INC - October 11, 2022

Source: https://www.globalkeysolutions.net/records/483/roe-dental-lab-inc/1f83f0c9-2a92-4805-9919-fddded058c9b

> FDA 483 for ROE DENTAL LAB INC on October 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ROE DENTAL LAB INC
- Inspection Date: 2022-10-11
- 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 September 26 to October 11, 2022. The inspection revealed significant deficiencies across its quality system, including unvalidated manufacturing processes, inadequate complaint handling, and a complete lack of a functional CAPA system. The firm also failed to establish proper controls for suppliers, non-conforming products, equipment calibration, internal audits, management reviews, and process controls.

## Related Documents

- [483 - 2023-10-23](https://www.globalkeysolutions.net/records/483/roe-dental-lab-inc/9a0a6b2e-6bc2-40db-9a11-ebf00144dff3)

## 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