FDA 483 - Integrated Laboratory Systems LLC, An Inotiv Company - May 17, 2024

Integrated Laboratory Systems LLC, An Inotiv Company in Morrisville, NC, a nonclinical laboratory, was issued a Form 483 following an FDA inspection. The inspection revealed significant deficiencies related to inadequate standard operating procedures for nonclinical studies, failure to promptly replace a study director, and the quality assurance unit's failure to document protocol deviations. These issues indicate potential concerns regarding data quality and integrity in their studies.