FDA 483 - Qualgen, LLC - September 04, 2025

Qualgen, LLC in Edmond, OK, was inspected and received a Form 483 with five observations, including repeat findings. The inspection revealed significant deficiencies in cross-contamination prevention, quality control unit adherence to procedures, environmental controls, and sterile product manufacturing processes. These issues indicate a systemic failure to ensure drug product quality, identity, strength, and purity.