FDA 483 - ICON Laboratory Services, Inc. - April 25, 2024
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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.
ID · 7480fc41-d13e-4456-8560-21d0042586f1