FDA 483 - Autumn Harp - April 30, 2025

An FDA inspection of Autumn Harp, Inc. in Essex Junction, VT, revealed deficient component testing practices. The firm failed to adequately test all containers of Glycerin USP 99.7% for ethylene glycol/diethylene glycol impurities, despite using this component in the manufacture of SPF sunscreen drug products. This indicates a significant lapse in quality control for raw materials.