FDA 483 - Ashland Specialty Ingredients, G.P. - December 22, 2025
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An FDA inspection of Ashland Specialty Ingredients, G.P. in Fiskeville, RI, a manufacturer of the Dose-map Blood Irradiator Dosimetry System, revealed six significant quality system deficiencies. The firm failed to adequately establish procedures for design verification, design input, process validation, corrective and preventive actions, and control of storage areas. Additionally, device history records were not properly maintained, indicating a lack of robust controls over the medical device's lifecycle.
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