FDA 483 - Sucampo Pharma, LLC

Sucampo Pharmaceuticals, LLC, an API manufacturer in Sanda, Japan, was cited for four observations during an FDA inspection. The inspection revealed issues including incomplete investigations into manufacturing deviations, unvalidated process parameters for drug substance dissolution, and inadequate investigation of product complaints. Additionally, the firm's gas chromatography instrument and software had a shared login and allowed data overwriting, raising data integrity concerns.