# FDA 483 - Cadence Science, Inc. - September 13, 2019

Source: https://www.keypedia.com/records/483/cadence-science-inc/e05b98a8-d30b-48c7-9778-e2c32f38b520

> FDA 483 for Cadence Science, Inc. on September 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cadence Science, Inc.
- Inspection Date: 2019-09-13
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Cadence Science, Inc. in Cranston, RI, was inspected and cited for significant failures in reporting device-related issues. The firm failed to report a field safety advisory notice for pressure control syringes and did not submit a required 5-day report for a medical device reportable event involving syringe breakage. These failures indicate serious lapses in post-market surveillance and reporting requirements for medical devices.

## Related Officers

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

Company: https://www.keypedia.com/companies/cadence-science-inc/9da92b56-732f-4285-87fe-4684f6cd1b15

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