FDA 483 - ILMO PRODUCTS COMPANY - March 28, 2024

ILMO Products Company, a medical gas manufacturer in Jacksonville, IL, was cited for significant deficiencies in its quality control and production processes. Observations included inadequate control over labeling, failure to follow written procedures for production and process controls, and insufficient computer system controls. Additionally, the firm lacked proper annual record review procedures and used expired laboratory standards, indicating a systemic breakdown in ensuring product quality and purity.