FDA 483 - Carefusion Corporation - September 19, 2025

Carefusion Corporation in Mannford, OK, received one observation during an FDA inspection concerning inadequate procedures for controlling nonconforming product. The firm's procedures contained conflicting guidance for distinguishing between normal process scrap and nonconformance, and they failed to adequately investigate nonconforming product related to welding defects. This indicates deficiencies in their quality system regarding product control and complaint investigation.