FDA 483 - Cardinal Health 414, Inc. - June 13, 2025

An FDA inspection of Cardinal Health 414, Inc., a PET drug manufacturer in Seattle, WA, revealed a significant deficiency in their quality assurance procedures. The firm failed to establish written procedures for documenting non-conformances, specifically lacking defined timelines for initiating records and failing to document the record initiation date. This indicates a breakdown in their quality system and record-keeping practices.