FDA 483 - Allergan Sales LLC - June 24, 2021

An FDA inspection of Allergan Sales LLC in Cincinnati, OH, revealed significant deficiencies in laboratory controls, stability testing, and quality unit responsibilities related to their Armour® Thyroid drug product. The firm lost critical method validation data, failed to establish and follow adequate stability programs, and did not thoroughly investigate discrepancies or properly handle product complaints. Several observations were repeats from previous inspections, indicating persistent quality system issues.