FDA 483 - Inotiv, Inc. - May 23, 2025

Inotiv, Inc. in Mount Vernon, IN, a nonclinical laboratory, was cited with five observations during an FDA inspection. The observations primarily concern significant deficiencies in Good Laboratory Practice (GLP) studies, including failures in timely archiving of study materials, inaccurate quality assurance statements, incomplete final study reports, and inconsistent specimen identification. These issues indicate a lack of robust data integrity and quality control within their nonclinical laboratory operations.