FDA 483 - EUROFINS ANIMAL HEALTH TESTING - November 08, 2024

An FDA inspection of Eurofins Animal Health Testing in Indianapolis, IN, revealed significant deficiencies in their nonclinical laboratory study practices. The firm's quality assurance unit failed to properly document deviations from protocols and SOPs, and studies were not consistently conducted in accordance with approved protocols. Additionally, the quality assurance unit did not maintain an accurate and timely master schedule sheet for all nonclinical laboratory studies.