Avatar Corporation
Form 483 issued April 25, 2016 · University Park, Illinois
- Inspection
- Apr 12 – Apr 25, 2016
- Investigator
- Brian D. Nicholson
- Observations
- 3
- Pages
- 2
- FEI number
- 1450491
In short: On April 25, 2016, FDA issued a Form 483 with 3 observations to Avatar Corporation in University Park, Illinois (FEI 1450491) after an inspection that ran Apr 12 – Apr 25, 2016. The investigator was Brian D. Nicholson. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×) · 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
Laboratory records do not always accurately indicate if a test has been performed on a specific…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Hoses used to transfer API products such as Pinnacle 225 API Lot 15-040-02 and other USP…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmAvatar Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avatar Corporation?
FDA listed 3 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 Avatar Corporation?
Brian D. Nicholson is named on this Form 483, for the inspection of Apr 12 – Apr 25, 2016. Each investigator has a profile showing what they cite most.
When was Avatar Corporation inspected by FDA?
The inspection ran Apr 12 – Apr 25, 2016, and the Form 483 is dated April 25, 2016.
How do I get the full Form 483 for Avatar Corporation?
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.