FDA EIR - inVentiv Health Clinical Lab, Inc. - November 08, 2019

An FDA surveillance inspection was conducted at inVentiv Health Clinical Lab, Inc. from November 4 to 8, 2019. The inspection, performed under the Bioanalytical BA/BE-Biosimilars Compliance Program Guidance Manual, focused on the firm's bioanalytical services for a specific investigative product. While no formal inspectional observations (FDA-483) were issued, three significant issues were discussed with management. The primary concerns centered on inadequate documentation and potential bias in method validation. Firstly, the company failed to document or report data from pre-testing experiments conducted to evaluate hemolysis effects during method validation. Secondly, there was no clear documentation explaining the selection of specific matrix lots for selectivity evaluation, and the firm acknowledged potential bias in this process. Finally, despite implementing a Standard Operating Procedure in 2017 to prevent pre-testing of samples before formal validation experiments, inVentiv Health Clinical Lab, Inc. had not performed a retrospective analysis to evaluate studies previously impacted by this practice. In response, the company proposed corrective actions including conducting new validation experiments for both hemolysis and selectivity using naive, untested matrix lots. Management also committed to internally review and develop a plan to address the lack of retrospective analysis for past studies.