FDA 483 - Sucampo Pharma, LLC

During an inspection from November 4-7, 2025, Sucampo Pharma, LLC, an API manufacturer in Sanda, Hyogo, Japan, was cited for inadequate testing practices. The primary concern was the insufficient re-qualification process for in-house primary reference standards. This indicates a significant issue with the firm's laboratory control system regarding the purity and reliability of its reference materials.