SI Group, Inc. – FDA EIR, Jan 17, 2025

An FDA inspection of SI Group, Inc., an active pharmaceutical ingredient (API) manufacturer in Orangeburg, SC, occurred from January 15 to January 17, 2025. This routine surveillance inspection, conducted under the Compliance Program Guidance Manual for API Process Inspections, focused on the firm's Quality, and Packaging and Labeling Systems. A Form FDA 483 was issued, outlining several observations. Major issues included scales in packaging operations not being properly calibrated or verified, a lack of proper second verification for packaged APIs, and uncertified areas within the packaging clean room. Verbal observations further noted the packaging room had not been recertified for nearly two years, an environmental monitoring excursion was not included in results, and written procedures for environmental monitoring lacked specific guidance on air sampling locations. Additionally, inconsistencies in equipment revalidation temperatures and incomplete oven calibrations were noted. SI Group, Inc. plans to address these deficiencies within 15 business days. The FDA reiterated the firm's responsibility to adhere to the Federal Food, Drug, and Cosmetic Act, warning that non-compliance could lead to enforcement actions. The inspection was classified as Voluntary Action Indicated (VAI).