Agnitio Inc.
Form 483 issued June 4, 2021 · Appleton, Wisconsin
- Inspection
- Jun 1 – Jun 4, 2021
- Investigator
- Norman K. Starks
- Observations
- 1
- Pages
- 2
- FEI number
- 3011690850
In short: On June 4, 2021, FDA issued a Form 483 with 1 observation to Agnitio Inc. in Appleton, Wisconsin (FEI 3011690850) after an inspection that ran Jun 1 – Jun 4, 2021. The investigator was Norman K. Starks. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program testing…
This inspection in context
Norman K. Starks
10 documents · 2018–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmAgnitio Inc. history
The site's inspection history, in date order.
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 Agnitio Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Agnitio Inc.?
Norman K. Starks is named on this Form 483, for the inspection of Jun 1 – Jun 4, 2021. Each investigator has a profile showing what they cite most.
When was Agnitio Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 4, 2021, and the Form 483 is dated June 4, 2021.
How do I get the full Form 483 for Agnitio 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.