FDA 483 - Thorn BioScience LLC - June 07, 2019

Thorn BioScience LLC in Louisville, KY, was inspected from June 3-7, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in computer system controls, including lack of system administrator accountability and audit trail review. Additionally, the firm lacked appropriate statistical quality control criteria for visual inspection, had incomplete laboratory records regarding analyst and reviewer signatures, and had deficient cleaning and maintenance procedures.