OXYGEN DEVELOPMENT, L.L.C. – FDA 483, Sep 11, 2025

Oxygen Development, L.L.C., an OTC manufacturer in Palm Springs, FL, was cited for significant deficiencies in its quality system, laboratory controls, and material handling during an FDA inspection. The firm failed to thoroughly investigate deviations and out-of-specification results, lacked adequate written procedures for raw material release, and did not ensure representative sampling of incoming components. These issues indicate a systemic breakdown in quality control practices that could impact product quality and safety.