FDA 483 - United Guardian Inc - September 04, 2025

United-Guardian, Inc., a pharmaceutical drug manufacturer in Hauppauge, NY, was cited with five observations during an FDA inspection. The observations primarily concern significant deficiencies in data integrity, quality control procedures, annual product reviews, environmental storage controls, and equipment qualification and maintenance. These issues indicate a lack of robust quality systems necessary to ensure drug product quality and compliance with cGMP requirements.