FDA 483 - Inotiv Inc

Inotiv, Inc. in West Lafayette, IN, a biopharmaceutics analytical facility, was cited with three observations during an FDA inspection from October 20-24, 2025. The observations primarily concern deficiencies in method validation for insulin aspart, specifically regarding the evaluation of lipemia effects, whole blood stability, and documentation of matrix utilization in validation experiments. These issues indicate a need for improved rigor and documentation in their analytical method validation processes.