FDA 483 - Bioreliance Corporation - January 29, 2026

BioReliance Corporation in Rockville, MD, a nonclinical laboratory, received a Form 483 with two observations. The inspection revealed failures by the study director to ensure protocol adherence, including conducting required risk assessments for non-GLP procedures. Additionally, the study director failed to note and resolve unforeseen circumstances, such as animal strain discrepancies and positive bacterial detections, which could impact study quality and integrity.