FDA 483 - Padagis US LLC - September 06, 2024

An FDA inspection of Padagis US LLC in Minneapolis, MN, a drug manufacturer, revealed deficiencies in equipment cleaning and maintenance procedures. Specifically, the firm failed to demonstrate the effectiveness of an un-validated cleaning procedure for a tank mixer used for drug components, including 'at-risk' ingredients. This indicates a significant concern regarding potential contamination and product quality.