# FDA 483 - CDR SYSTEMS, INC. - August 11, 2022

Source: https://www.keypedia.com/records/483/cdr-systems-inc/e9bbf393-dd71-496d-b761-82cce9fb1b9f

> FDA 483 for CDR SYSTEMS, INC. on August 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CDR SYSTEMS, INC.
- Inspection Date: 2022-08-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CDR SYSTEMS, INC. in Calgary revealed significant deficiencies in their quality system, particularly concerning supplier management, non-conforming product control, internal audits, and design review procedures. The inspection identified a repeat observation regarding the failure to perform quality audits, indicating persistent issues with their quality management. These findings suggest a need for comprehensive corrective actions to ensure compliance with medical device regulations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/cdr-systems-inc/e37b68bb-786f-4ebe-85e1-cafa2bae9848

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd