FDA 483 - Sucampo Pharma, LLC - November 07, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 04-07, 2025, at Sucampo Pharma, LLC in Sanda, Hyogo, Japan, a significant observation was made regarding the firm's laboratory system. The inspection revealed that testing performed to establish the purity of the in-house primary reference standard was inadequate. Specifically, the re-qualification process for the Active Pharmaceutical Ingredient (API) reference standard primarily consisted of only a related substances analytical test. Purity was then determined through a mass balance approach, which incorrectly utilized historical data for water content, residual solvents, and residue on ignition from the initial qualification of the reference standard, rather than re-testing these parameters. For instance, Lot Beof the Soyer! in-house reference standard was re-qualified in oo, yet it relied on initial qualification data from 2007 for these crucial purity tests. This deficiency in quality control processes raises concerns about the accuracy and reliability of the reference standards used in manufacturing. Sucampo Pharma, LLC is now required to promptly address this observation by investigating the root cause, implementing comprehensive corrective actions to ensure the robust re-qualification of their reference standards, and establishing preventive measures to maintain compliance with good manufacturing practices.