483
Central Indiana Ethanol LLCCentral Indiana Ethanol LLC – FDA 483, Apr 24, 2024
Record Details
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.
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ID · 562b4ea6-b0e7-4d5e-9ff5-812ab124a45f
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