FDA 483 - Elizabeth Arden, Inc. - May 30, 2025

An FDA inspection of Elizabeth Arden, Inc. in Salem, VA, a repacker of OTC drug products and cosmetics, revealed significant deficiencies in environmental controls. The firm failed to provide adequate equipment for humidity and temperature control, monitoring, and calibration in areas used for storing and packaging drug products. These issues raise concerns about the proper storage conditions for drug products.