FDA 483 - Cardinal Health, MSU P.E.T. Site - January 22, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 704c4731-2d9a-43cf-a144-b7487163726c