FDA 483 - Thorn BioScience LLC - May 22, 2024

Thorn BioScience LLC in Louisville, KY, was inspected by the FDA from May 14-22, 2024, and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results and discrepancies, insufficient equipment cleaning records, and improper reserve sample quantities. Additionally, issues were noted in computer system controls, procedures for preventing microbiological contamination of sterile products, and aseptic processing area disinfection protocols.