FDA EIR - Lovelace Biomedical Research Institute - September 13, 2019

Lovelace Respiratory Research Institute underwent an unannounced routine Good Laboratory Practice (GLP) inspection by the FDA from September 9-13, 2019, conducted under Compliance Program 7348.808 for nonclinical laboratories. The inspection verified that corrective actions from a previous 2016 inspection had been implemented. However, the current inspection identified two main observations issued on Form FDA 483. First, the study director failed to ensure accurate recording and verification of experimental data, specifically lacking documentation to confirm test article stability during dosing for two GLP studies. Second, the Quality Assurance Unit did not maintain a master schedule sheet with all required elements for nonclinical laboratory studies; this was noted as a repeat violation from the 2016 inspection.

Additional discussion items raised with management included inadequate separation of GLP/non-GLP, and test/control articles and their formulations; insufficient removal of expired test and control articles; incomplete documentation in HPLC user logs regarding performance checks; and inadequate labeling of test articles, particularly missing expiration dates. Management acknowledged the findings and committed to responding to the FDA 483 observations within 15 working days.