# FDA 483 - Synapse Biomedical Inc - October 07, 2020

Source: https://www.globalkeysolutions.net/records/483/synapse-biomedical-inc/7f938384-7e08-4a1a-9e20-baa8c0d27a76

> FDA 483 for Synapse Biomedical Inc on October 07, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synapse Biomedical Inc
- Inspection Date: 2020-10-07
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Synapse Biomedical Inc. in Oberlin, OH, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately validate critical processes, including sterile packaging and cleaning, and exhibited inadequate risk analysis for its NeuRx diaphragm stimulating device. Additionally, issues were noted in documenting non-conforming products, acceptance activities, and establishing clear procedures for supplier evaluation.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)
- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/synapse-biomedical-inc/ffbb8a14-9251-4211-b7e8-f97b89f8b9dc

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