# FDA 483 - Synapse Dental - November 01, 2021

Source: https://www.keypedia.com/records/483/synapse-dental/27318b4f-c4ab-445d-955b-83f198d14d75

> FDA 483 for Synapse Dental on November 01, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synapse Dental
- Inspection Date: 2021-11-01
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Synapse Dental in Cranston, RI, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design changes, acceptance activities, and complaint handling. These issues indicate a lack of robust controls over product design, incoming materials, and post-market surveillance for their Synapse Dental Pain Eraser device.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/synapse-dental/d28d0dc7-1647-4858-b320-869bb3caf70d

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94