Commonwealth Agri-Energy
Form 483 issued July 26, 2024 · HOPKINSVILLE, Kentucky
- Inspection
- Jul 22 – Jul 26, 2024
- Investigator
- Lisa R. Hilliard
- Observations
- 2
- Pages
- 4
- FEI number
- 3004617521
In short: On July 26, 2024, FDA issued a Form 483 with 2 observations to Commonwealth Agri-Energy in HOPKINSVILLE, Kentucky (FEI 3004617521) after an inspection that ran Jul 22 – Jul 26, 2024. The investigator was Lisa R. Hilliard. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
For the production of High Quality (HQ) or USP Grade 190 Proof Ethanol and USP Grade…
- 02
The on-going stability testing program does not monitor the stability characteristics and confirm appropriate storage conditions…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmCommonwealth Agri-Energy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Commonwealth Agri-Energy?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Commonwealth Agri-Energy?
Lisa R. Hilliard is named on this Form 483, for the inspection of Jul 22 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Commonwealth Agri-Energy inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Commonwealth Agri-Energy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.