FDA 483 - Central Indiana Ethanol LLC - April 24, 2024

An FDA inspection of Central Indiana Ethanol LLC, an API manufacturer in Marion, IN, revealed significant deficiencies across its laboratory, quality, and facilities/equipment systems. The firm failed to validate analytical methods, implement adequate computerized system controls, and ensure proper quality unit review for batch release. These issues indicate a lack of control over critical processes for their 190 USP Ethyl Alcohol product.