FDA 483 - Biomedical Research Models, Inc. d/b/a Biorep - May 29, 2026

Biomedical Research Models, Inc. d/b/a Biorep, a nonclinical laboratory in Worcester, MA, was cited for significant data integrity issues during an FDA inspection. The study director failed to ensure accurate recording and verification of experimental data, leading to discrepancies between pathology reports and raw data concerning tissue collection and findings in non-clinical studies. This indicates a serious breakdown in data management and quality control for research models.