483
Thorn BioScience LLCFDA 483 - Thorn BioScience LLC - May 26, 2023
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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.
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ID · cd3ae3c9-27ad-43ff-877f-508e436ced9d