# FDA 483 - Immuno-Mycologics, Inc - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/immuno-mycologics-inc/e13e2d2f-2f8a-4676-88f0-31304ae1544f

> FDA 483 for Immuno-Mycologics, Inc on July 14, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immuno-Mycologics, Inc
- Inspection Date: 2023-07-14
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Immuno-Mycologics, Inc. in Norman, OK, a medical device manufacturer, was cited for two significant quality system deficiencies during an FDA inspection. The firm failed to adequately validate a design change for its CrAg Lateral Flow Assay, specifically regarding the interchangeability of sourced antibodies. Additionally, the company did not properly establish and maintain requirements for its critical suppliers, failing to complete required annual vendor reviews.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/olalere-d-fasipe/0dd0f0ae-07d9-40ab-b602-97521150d23d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab