FDA 483 - SI Group, Inc. - January 15, 2025

SI Group, Inc. in Orangeburg, SC, an Active Pharmaceutical Ingredient manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in the calibration and verification of scales used in Propofol API packaging operations, a lack of proper second verification for packaged API weight, and uncertified areas within the packaging cleanroom. These issues indicate potential concerns with quality control and environmental monitoring in their manufacturing processes.