FDA 483 - Cardinal Health, MSU P.E.T. Site - January 22, 2026

An FDA inspection of Cardinal Health, MSU P.E.T. Site in East Lansing, MI, from January 20-22, 2026, revealed a significant issue with the firm's corrective action processes. The company failed to thoroughly implement adequate corrective actions for multiple recurring non-conformances and out-of-specification events related to cassette set-up, which resulted in numerous rejected batches. Despite identifying human error as the cause, the events continued to recur, indicating ineffective CAPA implementation.