FDA 483 - SI Group, Inc. - January 17, 2025

During an inspection conducted from January 15-17, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to SI Group, Inc., an Active Pharmaceutical Ingredient (API) manufacturer located in Orangeburg, SC. The inspection revealed three significant observations indicating potential non-compliance with manufacturing quality standards, primarily affecting the Propofol API packaging operations. The first observation cited improper calibration and verification of scales. Specifically, scales were not calibrated using weights representative of the product’s actual packaged weight, and a weight used for daily verification lacked certification. Secondly, the FDA noted a lack of independent verification for packaged Propofol API weights, as the same individual performed both packaging and weight verification, raising concerns about data integrity. Lastly, the inspection found that the gowning room within the Propofol API packaging clean room had not been qualified since its construction in 2019, and air monitoring was not comprehensive throughout the entire clean room. These observations highlight concerns regarding process control, quality assurance, and environmental monitoring. SI Group, Inc. is required to provide a robust response detailing corrective and preventive actions to address these findings and ensure compliance with regulatory expectations.