Immuno-Mycologics, Inc – FDA 483, Mar 5, 2026

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.