FDA 483 - ICON Laboratory Services, Inc. - April 25, 2024

An FDA inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, identified a significant deviation from the firm's Standard Operating Procedures (SOPs) for LC-MS analysis. The firm failed to correctly process and report re-analysis results for study samples, including misapplying calculation rules and conducting unauthorized single repeat analyses. This indicates a moderate severity issue concerning adherence to established quality control procedures in bioanalytical testing.