FDA 483 - Autumn Harp - December 19, 2019

An FDA inspection of Autumn Harp in Essex Junction, VT, a drug manufacturer, revealed significant deficiencies in laboratory control mechanisms, equipment maintenance, and record-keeping. Observations included failure to follow OOS investigation procedures, lack of instrument calibration checks after repair, shared user logins without audit trails, and unsanitary conditions in a raw material sampling booth. These issues indicate a lack of adequate controls to ensure the quality and purity of OTC topical drug products.