FDA 483 - Commonwealth Agri-Energy LLC - July 26, 2024

An FDA inspection of Commonwealth Agri-Energy, LLC, an API manufacturer in Hopkinsville, KY, revealed significant deficiencies in quality-related procedures for the production of High Quality (HQ) or USP Grade 190 Proof Ethanol. Observations included a lack of established written procedures for critical quality topics, inadequate documentation of QA reviews, insufficient training records, and unvalidated water systems. Additionally, the firm's ongoing stability testing program for HQ Ethanol was found to be deficient, lacking appropriate procedures and protocols to support expiration dates.