# FDA 483 - Cordis Corporation - January 12, 2018

Source: https://www.keypedia.com/records/483/cordis-corporation/cd5e7d1c-e055-4312-ba9c-f694c946012e

> FDA 483 for Cordis Corporation on January 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cordis Corporation
- Inspection Date: 2018-01-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Cordis Corporation in Milpitas, CA, revealed a significant issue regarding the timely reporting of unanticipated adverse device effects (UADEs). The firm failed to submit reports of suprarenal stent fractures to all reviewing IRBs and participating investigators within the required 10 working days. This constitutes a deviation from their investigational plan and regulatory expectations for device safety reporting.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)

Company: https://www.keypedia.com/companies/cordis-corporation/99bd3721-1fb0-4825-ab75-e720e3656d00

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b