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

Source: https://www.keypedia.com/records/483/commonwealth-agri-energy-llc/079fe5e7-ab07-467e-8620-899d4acfa65d

> FDA 483 for Commonwealth Agri-Energy LLC on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Commonwealth Agri-Energy LLC
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.keypedia.com/companies/commonwealth-agri-energy-llc/1c6739a9-7262-4b58-a5b7-c4c91eaca846

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22