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

Eurofins Animal Health Testing in Indianapolis, IN, a nonclinical laboratory, was cited for significant deficiencies in its quality assurance unit and adherence to study protocols. The inspection revealed failures in documenting deviations from approved procedures, conducting studies according to protocol, and maintaining complete master schedule sheets for nonclinical laboratory studies. These issues indicate a lack of robust quality system oversight and control over critical study processes.