FDA 483 - Inotiv, Inc - October 24, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 20-24, 2025, at Inotiv, Inc.'s Biopharmaceutics Analytical Facility & Nonclinical Laboratory in West Lafayette, IN, several regulatory observations were noted in an FDA Form 483. The inspection highlighted deficiencies primarily related to analytical method validation for insulin aspart.

Specifically, the company failed to properly evaluate the effect of lipemia for selectivity and matrix effect experiments during the validation of insulin aspart in human serum, using plasma instead of serum. Furthermore, whole blood stability of insulin aspart was not assessed during method validation; short-term stability testing was also conducted using plasma. A third significant observation detailed that source records for various method validation experiments, including long-term stability, dilution integrity, stability in matrix, and ion suppression, did not adequately document the use of lithium heparinized human lysed whole blood as the matrix, despite its utilization in actual study samples.

These inspectional observations indicate deviations from expected laboratory practices for analytical method validation. Inotiv, Inc. is required to address these findings and implement appropriate corrective actions to ensure the integrity and reliability of their analytical data and processes.