# FDA 483 - iVu Imaging Corp - March 05, 2025

Source: https://www.keypedia.com/records/483/ivu-imaging-corp/4339c4f2-ff3a-4fd2-82a5-ba3aa4870246

> FDA 483 for iVu Imaging Corp on March 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: iVu Imaging Corp
- Inspection Date: 2025-03-05
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of iVU Imaging Corp, a medical device manufacturer in Southlake, TX, identified one observation related to their quality system. The firm's device history records did not demonstrate that devices were manufactured in accordance with regulations, specifically regarding the maintenance of complete labeling records. This indicates a moderate severity finding concerning documentation and quality control practices.

## Related Officers

- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/ivu-imaging-corp/a8d8e39e-7000-4fbf-adc1-8b11fd77086f

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9