# FDA 483 - Summit Orthodontic Services Inc - November 06, 2019

Source: https://www.globalkeysolutions.net/records/483/summit-orthodontic-services-inc/9d60c336-c153-4dd0-a43e-bcb1003e0202

> FDA 483 for Summit Orthodontic Services Inc on November 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summit Orthodontic Services Inc
- Inspection Date: 2019-11-06
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Summit Orthodontic Services Inc, a medical device labeler/relabeler in Munroe Falls, OH, received a Form FDA-483 citing significant quality system deficiencies. The inspection revealed a lack of documented procedures and records for supplier evaluation, control, and approval. Additionally, the firm failed to establish adequate document control procedures.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/summit-orthodontic-services-inc/126073ea-f930-417f-9a13-852101f39f4b

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