FDA 483 - Inotiv Inc - October 24, 2025

During an inspection conducted from October 20-24, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Inotiv, Inc.'s Biopharmaceutics Analytical Facility & Nonclinical Laboratory in West Lafayette, Indiana. The inspection revealed three significant observations primarily concerning method validation for insulin aspart.

Firstly, the firm did not adequately evaluate the effect of lipemia on selectivity and matrix effect experiments during the validation of insulin aspart in human serum, instead using plasma matrix for these crucial assessments. Secondly, the whole blood stability of insulin aspart was not assessed during method validation, with short-term stability testing performed solely in plasma. Finally, source records for several critical method validation experiments, including long-term stability, dilution integrity, stability in matrix, and ion suppression, failed to document the use of lithium heparinized human lysed whole blood as the matrix, despite its actual use in associated study samples.

These observations highlight deficiencies in the company's analytical method validation processes. Inotiv, Inc. is expected to address these findings by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for analytical testing and documentation in nonclinical laboratory settings.