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

Source: https://www.keypedia.com/records/483/central-indiana-ethanol-llc/562b4ea6-b0e7-4d5e-9ff5-812ab124a45f

> FDA 483 for Central Indiana Ethanol LLC on April 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Central Indiana Ethanol LLC
- Inspection Date: 2024-04-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)

Company: https://www.keypedia.com/companies/central-indiana-ethanol-llc/487c045a-ef1d-4d19-9fc4-0c3db45cb1c8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0