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

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.