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