FDA 483 - Ashland Specialty Ingredients, G.P. - February 17, 2023

An FDA inspection of Ashland Specialty Ingredients, G.P. in Bridgewater, NJ, revealed a significant quality system deficiency. The firm failed to revalidate a manufacturing process after implementing a new film inspection step for its GAFCHROMICTM EBT3 film, neglecting to document the evaluation or validation of this critical change. This indicates a breakdown in change control and process validation procedures.