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

During an inspection conducted from April 17 to April 24, 2024, the FDA issued a Form 483 to Central Indiana Ethanol LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Marion, IN. The inspection revealed significant observations primarily concerning the firm's laboratory, quality, and facilities/equipment systems, indicating potential non-compliance with Good Manufacturing Practices. Key issues included a lack of validated analytical methods for release testing of their 190 USP Ethyl Alcohol product. Numerous test methods, including those for gas chromatography, specific gravity, pH calibration, and various spectroscopies, were either unvalidated or their verification was incomplete, despite being used for numerous batches since 2021. Furthermore, the firm demonstrated inadequate controls over computerized systems in its Quality Control laboratory, failing to ensure data integrity and prevent unauthorized access or changes. The Quality Unit's oversight was also deficient, as batch production records were not consistently reviewed prior to API distribution, and their critical roles and responsibilities were not clearly documented. Deviations from established nonconforming materials procedures were neither documented nor investigated. Finally, the inspection noted an absence of written procedures for cleaning equipment, such as tanker trucks and railcars, used for the distribution of the API. These observations require Central Indiana Ethanol LLC to implement comprehensive corrective actions to ensure compliance with regulatory standards.