# FDA 483 - Omega Medical Imaging, Inc. - August 26, 2022

Source: https://www.keypedia.com/records/483/omega-medical-imaging-inc/1707c91b-dd3c-4f4e-b4f6-77262d5e7f1a

> FDA 483 for Omega Medical Imaging, Inc. on August 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Medical Imaging, Inc.
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Omega Medical Imaging, Inc. in Sanford, FL, was inspected regarding its manufacturing processes for medical devices. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for corrective and preventive actions and the control of nonconforming products. These issues indicate a failure to properly address and document product discrepancies and prevent their recurrence.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/omega-medical-imaging-inc/74d04b67-394a-442a-b4f2-08d3f58760c3

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