# FDA 483 - Cordis US Corp - June 29, 2022

Source: https://www.globalkeysolutions.net/records/483/cordis-us-corp/2f618886-300c-4bdb-9435-92f09ba6a965

> FDA 483 for Cordis US Corp on June 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cordis US Corp
- Inspection Date: 2022-06-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Cordis US Corp in Miami Lakes, FL, revealed significant deficiencies in the firm's design control procedures for their (b)(4) Stent, particularly concerning a new pediatric indication. Observations cited inadequate establishment of procedures for design verification, design input documentation, design validation, and design review. These issues indicate a lack of robust controls to ensure the safety and effectiveness of the device for its intended use.

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/cordis-us-corp/0356db58-939c-4049-b5a9-010a14550d56

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6