FDA 483 - Integrated Laboratory Systems LLC, An Inotiv Company - September 30, 2022

An FDA inspection of Integrated Laboratory Systems LLC, An Inotiv Company in Morrisville, NC, a nonclinical laboratory, revealed significant deficiencies in their adherence to Good Laboratory Practices. Observations included failures in assuring personnel understanding of functions, inadequate standard operating procedures for various laboratory methods, and a lack of established SOPs for histopathology. These issues indicate a systemic problem with quality and data integrity in their nonclinical studies.