FDA 483 - Lovelace Biomedical Research Institute - September 13, 2019

Lovelace Respiratory Research Institute was cited for deficiencies in assuring data integrity and maintaining quality assurance during nonclinical laboratory studies. The inspection revealed that the study director failed to ensure accurate recording and verification of experimental data, specifically regarding test article preparation. Furthermore, the quality assurance unit did not maintain a complete master schedule for all nonclinical laboratory studies.