FDA 483 - Sucampo Pharma, LLC

An FDA inspection of Sucampo Pharma, LLC in Sanda, Hyogo, Japan, identified an inadequacy in the testing procedures for establishing the purity of in-house primary reference standards. The firm's re-qualification process for API reference standards was found to be insufficient, as it relied on initial qualification test results for certain parameters rather than current testing. This observation highlights a concern regarding the quality control of critical reference materials used in manufacturing.