# FDA 483 - Immuno-Mycologics, Inc - March 05, 2026

Source: https://www.keypedia.com/records/483/immuno-mycologics-inc/53a6012f-004d-433c-89e8-9b764f9e969c

> FDA 483 for Immuno-Mycologics, Inc on March 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immuno-Mycologics, Inc
- Inspection Date: 2026-03-05
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Immuno-Mycologics, Inc. in Norman, OK, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately maintain records of risk management activities for their Class II products and did not properly review, verify, validate, and approve design and development changes before implementation. These issues indicate a lack of robust control over product quality and safety.

## Related Documents

- [483 - 2023-07-14](https://www.keypedia.com/records/483/immuno-mycologics-inc/e13e2d2f-2f8a-4676-88f0-31304ae1544f)

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.keypedia.com/companies/immuno-mycologics-inc/ae4957ea-9106-46f0-add9-47474432c588

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