FDA 483 - Orange Lab Holdings - July 19, 2024

Orange Lab Holdings in Anaheim, CA, was inspected by the FDA, revealing significant and repeat deficiencies in their manufacturing of OTC drug and cosmetic products. The firm lacks adequate quality control procedures, has unvalidated cleaning and manufacturing processes, and exhibits poor control over computer systems and employee training. Additionally, there are failures in investigating out-of-specification results, maintaining equipment calibration, and adhering to a written stability program.