FDA 483 - Particle Dynamics LLC - April 14, 2025

An FDA inspection of Particle Dynamics LLC in Seymour, IN, an API manufacturer, revealed a significant failure in equipment maintenance and suitability. The firm was cited for not ensuring that equipment surfaces in contact with active pharmaceutical ingredients (APIs) do not alter product quality. Specifically, corrosion and rust were observed on critical manufacturing equipment used for Calcium Carbonate APIs, indicating a lapse in quality assurance and equipment integrity.