Lovelace Biomedical Research Institute – FDA 483, Apr 18, 2025

An FDA inspection of Lovelace Biomedical Research Institute in Albuquerque, NM, revealed multiple deficiencies in their nonclinical laboratory study practices. Key issues included inadequate study director oversight, improper handling and testing of test/control articles, and failures in documentation and record retention. These observations indicate a need for significant improvements in adherence to regulatory requirements for nonclinical studies.