FDA 483 - Lovelace Biomedical Research Institute - November 11, 2016

The FDA issued a Form 483 to Lovelace Respiratory Research Institute in Albuquerque, NM, following an inspection of their GLP laboratory. The inspection revealed significant deficiencies across nine observations, primarily concerning non-compliance with Good Laboratory Practice regulations related to test article characterization, study director responsibilities, record keeping, standard operating procedures, and the oversight functions of the quality assurance unit. These issues indicate systemic failures in maintaining the integrity and quality of nonclinical laboratory studies.