Roquette America, Inc.
Form 483 issued January 30, 2026 · Keokuk, Iowa
- Inspection
- Jan 27 – Jan 30, 2026
- Investigators
- Kelly M. Bromley· Tyler Peterson
- Observations
- 3
- Pages
- 3
- FEI number
- 1910565
In short: On January 30, 2026, FDA issued a Form 483 with 3 observations to Roquette America, Inc. in Keokuk, Iowa (FEI 1910565) after an inspection that ran Jan 27 – Jan 30, 2026. The investigators were Kelly M. Bromley and Tyler Peterson. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to ensure adequate control over…
- 02
You failed to adequately investigate the root cause of the failure for batches…
- 03
You failed to ensure adequate control over the quarantine and disposition of rejected materials to…
This inspection in context
Kelly M. Bromley
4 documents · 2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmRoquette America, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roquette America, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Roquette America, Inc.?
Kelly M. Bromley and Tyler Peterson are named on this Form 483, for the inspection of Jan 27 – Jan 30, 2026. Each investigator has a profile showing what they cite most.
When was Roquette America, Inc. inspected by FDA?
The inspection ran Jan 27 – Jan 30, 2026, and the Form 483 is dated January 30, 2026.
How do I get the full Form 483 for Roquette America, Inc.?
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.