FDA 483 - Thorn BioScience LLC - May 26, 2023

An FDA inspection of Thorn BioScience LLC in Louisville, KY, a manufacturer, revealed significant deficiencies in laboratory control mechanisms and quality review processes. The firm's analysts could delete raw data without adequate controls or audit trails, indicating a severe data integrity issue. Additionally, the company failed to perform an annual product quality review for Sucramate and lacked proper procedures for inspecting retain samples.