FDA EIR - Lovelace Biomedical Research Institute - January 31, 2020

An FDA inspection was conducted at Lovelace Biomedical Research Institute in Albuquerque, NM, from January 27 to January 31, 2020. This routine inspection, focusing on Good Laboratory Practice (GLP) for nonclinical studies supporting FDA marketing applications, uncovered several critical compliance deficiencies. At the conclusion of the inspection, the firm was issued an FDA Form 483 citing two main violations: a failure to retain all raw data generated from a nonclinical laboratory study and a failure to ensure that challenge agents were appropriately tested for identity. Further findings detailed throughout the inspection reports included a consistent lack of robust data integrity practices. Specifically, inspectors noted instances of missing non-GLP study records, inadequate characterization of test materials, unverified or retrospectively altered data entries, and insufficient justification for data changes. Significant issues were also identified in protocol deviation documentation, reconciliation of manual and electronic records, and the management of archival processes for non-GLP materials. Additionally, practices such as pre-signed study director forms and inconsistent application of critical observation criteria raised concerns about study oversight. Lovelace Biomedical Research Institute acknowledged the observations outlined in the FDA Form 483, and while immediate corrective actions were not promised during the close-out, a written response was subsequently received. These findings underscore the necessity for the institute to implement comprehensive improvements in its data management, record retention, and overall adherence to GLP regulations governing nonclinical research.