FDA 483 - Avantor Inc. - May 27, 2025

An FDA inspection of Avantor Performance Materials, LLC in Phillipsburg, NJ, an API manufacturer, identified one observation. The firm was cited for not verifying the suitability of test methods for active pharmaceutical ingredients under actual conditions of use. Specifically, analytical method verification studies for USP methods used in release and stability testing for API products marketed in the U.S. were not completed.