FDA 483 - Central Solutions Inc - April 02, 2025

An FDA inspection of Central Solutions, Inc. in Kansas City, KS, revealed significant deficiencies in their manufacturing and quality control processes for drug products, including hand sanitizers. The firm failed to adequately test incoming components for contaminants, ensure microbial control, maintain a robust stability program, and properly investigate out-of-specification results. Additionally, issues were noted with process validation, batch record accuracy, and written procedures for quality control, indicating a broad lack of adherence to good manufacturing practices.