FDA 483 - OXYGEN DEVELOPMENT, L.L.C. - January 17, 2018

Oxygen Development, LLC, a drug manufacturer in Palm Springs, FL, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The firm failed to investigate out-of-specification results, adhere to stability testing programs, and validate manufacturing processes for OTC drug products. These issues indicate a systemic lack of adherence to current good manufacturing practices, potentially impacting the identity, strength, quality, and purity of drug products.