Upsher-Smith Laboratories, LLC – FDA 483, Nov 7, 2019

An FDA inspection of USL Pharma Inc. dba Upsher-Smith Laboratories, LLC in Denver, CO, a drug manufacturer, revealed significant deficiencies in quality control and sanitation practices. Observations included failures to thoroughly investigate unexplained discrepancies related to equipment cleanliness and microbial contamination, as well as a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products. These findings suggest potential risks to drug product quality and patient safety.