FDA 483 - Afton Scientific, LLC - April 06, 2023

An FDA inspection of Afton Scientific, LLC in Charlottesville, VA, a sterile manufacturer, revealed three significant observations. The firm was cited for using equipment not appropriately designed for cleaning and maintenance, specifically rusted tongs in an aseptic processing area. Additionally, the inspection found a lack of established written procedures for equipment cleaning and maintenance, with cleaning efficacy studies failing to validate methods for an active pharmaceutical ingredient. Finally, the firm failed to follow its own written procedures for testing and approving drug product containers, specifically neglecting bioburden and endotoxin testing for vials since 2019.