Lovelace Biomedical Research Institute – FDA Warning Letter, Apr 18, 2025

The FDA issued a Warning Letter to Lovelace Biomedical Research Institute (LBRI) following an inspection of its Albuquerque facility between April 7 and 18, 2025. The inspection, conducted under the Bioresearch Monitoring Program, revealed that LBRI failed to comply with Good Laboratory Practice (GLP) regulations and the Federal Food, Drug, and Cosmetic Act. The primary violation involved the Quality Assurance Unit’s failure to ensure that final study reports accurately reflected the raw data collected during nonclinical laboratory studies. Specifically, investigators found that reports for two drug protocols omitted significant clinical observations, such as animal illness symptoms, and failed to document dosing complications, including animals removing their catheters and instances of medication leaking into surrounding tissues. While LBRI submitted initial corrective actions and updated its internal operating procedures, the FDA deemed the response inadequate due to a lack of detail regarding staff training, specific procedural updates, and future audit plans. These failures raise concerns about the integrity of the data generated at the facility. LBRI is required to provide a written response within 15 business days detailing comprehensive corrective actions and preventive measures to ensure future regulatory compliance. Failure to address these issues adequately may result in further regulatory action.