FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - September 20, 2023

Dercher Enterprises, Inc., DBA Gordon Laboratories, an OTC drug manufacturer in Upper Darby, PA, received a Form 483 with nine observations during an inspection from September 11-20, 2023. The inspection revealed significant deficiencies in process validation, stability testing, component testing, quality control unit responsibilities, and record-keeping, with several issues being repeat observations from previous inspections. The firm also failed to maintain adequate cleaning procedures, proper storage conditions, and sanitary facility conditions.