FDA 483 - United Guardian Inc - September 04, 2025

United-Guardian, Inc. in Hauppauge, NY, a pharmaceutical drug manufacturer, was inspected and cited for multiple significant deficiencies. Observations included failures in data integrity controls, inadequate production and process control procedures, neglected annual product reviews, improper drug product storage conditions, and insufficient equipment qualification and maintenance. These issues indicate a lack of robust quality systems and adherence to cGMP requirements.