FDA 483 - United Guardian Inc - August 02, 2018

United Guardian, Inc., a pharmaceutical drug manufacturer in Hauppauge, NY, was inspected by the FDA from July 24 to August 2, 2018. The inspection revealed significant deficiencies across multiple areas of their quality system, including a lack of validated manufacturing processes, analytical methods, and equipment, as well as inadequate storage conditions, computer system controls, and adherence to written procedures for product reviews and sample retention. These findings indicate a broad failure to ensure drug product identity, strength, quality, and purity.