Roquette America, Inc.
Form 483 issued June 17, 2021 · Keokuk, Iowa
- Inspection
- Jun 14 – Jun 17, 2021
- Investigators
- Carl A. Huffman II· Jill Tillman
- Observations
- 2
- Pages
- 2
- FEI number
- 1910565
In short: On June 17, 2021, FDA issued a Form 483 with 2 observations to Roquette America, Inc. in Keokuk, Iowa (FEI 1910565) after an inspection that ran Jun 14 – Jun 17, 2021. The investigators were Carl A. Huffman II and Jill Tillman. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
From November 2018 until November 2019 you did not perform resolution or system suitability for HPLC…
- 02
You lack control over how many copies your production employees in refinery can print to record…
This inspection in context
Carl A. Huffman II
1 document · 2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Iowa.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roquette America, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Roquette America, Inc.?
Carl A. Huffman II and Jill Tillman are named on this Form 483, for the inspection of Jun 14 – Jun 17, 2021. Each investigator has a profile showing what they cite most.
When was Roquette America, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 17, 2021, and the Form 483 is dated June 17, 2021.
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.