FDA 483 - Integris Bioservices LLC - October 20, 2023

KCAS Bioanalytical & Biomarker Services in Olathe, KS, a biopharmaceutical analytical facility, was inspected from October 16-20, 2023. The inspection revealed significant issues with data integrity and reporting practices related to sample analysis. Specifically, the firm failed to report all reanalyzed samples and did not accurately document study activities and information in bioanalytical reports.