FDA 483 - Avantor Performance Materials LLC - November 13, 2024

The FDA inspected Avantor Performance Materials LLC in Paris, KY, a repacker of APIs and excipients, and identified significant deficiencies. The observations highlight issues with laboratory controls, inadequate investigation of discrepancies, poor equipment cleaning and maintenance, and unsanitary facility conditions. These findings indicate a lack of adherence to good manufacturing practices, which could compromise product quality and purity.