FDA 483 - Bioreliance Corporation - November 22, 2024

Bioreliance Corporation in Rockville, MD, a control testing laboratory, was cited for two observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies and out-of-specification results, lacking scientific justification for retesting and assigning root causes. Additionally, the firm's practice of retesting OOS samples based on client memoranda lacked documentation for qualified dilutions and justification for changes in dilution factors.