Central Indiana Ethanol
Form 483 issued April 24, 2024 · Marion, Indiana
- Inspection
- Apr 17 – Apr 24, 2024
- Investigator
- Muna Algharibeh
- Observations
- 5
- Pages
- 3
- FEI number
- 3008674328
In short: On April 24, 2024, FDA issued a Form 483 with 5 observations to Central Indiana Ethanol in Marion, Indiana (FEI 3008674328) after an inspection that ran Apr 17 – Apr 24, 2024. The investigator was Muna Algharibeh. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm did not validate analytical methods used in the release testing of 190 USP Ethyl…
- 02
Your firm did not implement controls over computerized systems necessary to ensure the integrity of electronic…
- 03
Your quality unit did not review batch production records prior to…
- 04
Your firm did not document or explain a deviation from your established procedure, Q-984 titled “Control…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmCentral Indiana Ethanol history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Indiana Ethanol?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Central Indiana Ethanol?
Muna Algharibeh is named on this Form 483, for the inspection of Apr 17 – Apr 24, 2024. Each investigator has a profile showing what they cite most.
When was Central Indiana Ethanol inspected by FDA?
The inspection ran Apr 17 – Apr 24, 2024, and the Form 483 is dated April 24, 2024.
How do I get the full Form 483 for Central Indiana Ethanol?
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.